Methicillin-Resistant Staphylococcus AureusPhase 3NCT02814916
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
A Phase 3 study testing Dalbavancin, Vancomycin and Oxacillin in people with Methicillin-Resistant Staphylococcus Aureus and Bacterial Infections, run by AbbVie at 84 sites in 20 countries.
Trial summary
To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections, Staphylococcal Skin Infections
- What is being tested?
- Dalbavancin, Vancomycin and Oxacillin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 84 sitesin 20 countries
- Study dates
- 30 Mar 2017to 1 Jan 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients birth to 17 years (inclusive)
- A clinical picture compatible with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) suspected or confirmed to be caused by Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA).
- In addition to local signs of ABSSSI, the patient has at least one of the following:
- Fever, defined as body temperature ≥ 38.4°C (101.2°F) taken orally, ≥ 38.7°C (101.6°F) tympanically, or ≥ 39°C (102.2°F) rectally (core temperature) OR
- Leukocytosis (WBC > 10,000 mm3) or leukopenia (WBC < 2,000 mm3) or left shift of >10% band neutrophils
- Infection either involving deeper soft tissue or requiring significant surgical intervention
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- Major cutaneous abscess characterized as a collection of pus within the dermis or deeper that is accompanied by erythema, edema and/or induration which i. requires surgical incision and drainage, and ii. is associated with cellulitis such that the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR iii. alternatively, involves the central face and is associated with an area of erythema of at least 15 cm2 b. Surgical site or traumatic wound infection characterized by purulent drainage with surrounding erythema, edema and/or induration which occurred within 30 days after the trauma or surgery and is associated with cellulitis such that: i. the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, involves the central face and is associated with an affected area of at least 15 cm2 c. Cellulitis, defined as a diffuse skin infection characterized by spreading areas of erythema, edema and/or induration and: i. is associated with erythema that involves at least 35 cm2 of surface area, or surface area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, cellulitis of the central face that is associated with an affected area of at least 15 cm2 5. In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of ABSSSI: a. Purulent drainage/discharge b. Fluctuance c. Heat/localized warmth d. Tenderness to palpation e. Swelling/induration
- In patients age birth to < 3 months, each patient must meet the following inclusion criteria to be enrolled in this study.
- Male or female patients from birth to < 3 months of age, including pre-term neonates (gestational age ≥ 32 weeks)
- A clinical picture compatible with an ABSSSI suspected or confirmed to be caused by Gram-positive bacteria, including MRSA.
- OR
- Suspected or confirmed sepsis including any of the following clinical criteria:
- Hypothermia (<36°C) OR fever (>38.5°C)
- Bradycardia OR tachycardia OR rhythm instability
- Hypotension OR mottled skin OR impaired peripheral perfusion
- Petechial rash
- New onset or worsening of apnea episodes OR tachypnea episodes OR increased oxygen requirements OR requirement for ventilation support
- Feeding intolerance OR poor sucking OR abdominal distension
- Irritability
- Lethargy
- Hypotonia
- In addition, patients must meet at least one of the following laboratory criteria:
- White blood cell count ≤4.0 × 10^9/L OR ≥20.0 × 10^9/L b, Immature to total neutrophil ratio >0.2 c. Platelet count ≤100 × 10^9/L d. C-reactive protein (CRP) >15 mg/L OR procalcitonin ≥ 2 ng/mL e. Hyperglycemia OR Hypoglycemia f. Metabolic acidosis
- Infections must be of sufficient severity to merit hospitalization and parenteral antibiotic therapy. These infections may include:
- Cutaneous or subcutaneous abscess
- Surgical site or traumatic wound infection
- Cellulitis, Erysipelas
- Omphalitis
- Impetigo and bullous impetigo
- Pustular folliculitis
- Scarlet fever
- Staphylococcal scalded skin syndrome
- Streptococcal toxic shock syndrome
- Erythematous based-erosion
- Other infections originating in the skin or subcutaneous tissue and associated with signs and symptoms of sepsis as defined in Inclusion Criterion 2.
- Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study.
Who cannot join
- Patients age 3 months to 17 years: Clinically significant renal impairment, defined as calculated creatinine clearance of less than 30 mL/min. (calculated by the Schwartz "bedside" formula). Patients birth to < 3 months of age: Moderate or severe renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal (× ULN) for age OR urine output < 0.5 mL/kg/h (measured over at least 8 hours prior to dosing) OR requirement for dialysis.
- Clinically significant hepatic impairment, defined as serum bilirubin or alkaline phosphatase greater than 2 times the upper limits of normal (ULN) for age, and/or serum aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal (ULN) for age.
- Treatment with an investigational drug within 30 days preceding the first dose of study medication.
- Patients with sustained shock defined as systolic blood pressure < 90 mm Hg in children ≥ 10 years old, < 70 mm Hg + [2 x age in years] in children 1 to <10 years, or < 70 mmHg in infants 3 to <12 months old for more than 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure.
- More than 24 hours of any systemic antibacterial therapy within 96 hours before randomization. EXCEPTION: Microbiological or clinical treatment failure with a systemic antibiotic other than IV study drug that was administered for at least 48 hours. Failure must be confirmed by either a microbiological laboratory report or documented worsening clinical signs or symptoms.
- Infection due to an organism known prior to study entry to be resistant to dalbavancin (dalbavancin minimum inhibitory concentration (MIC) greater than 0.25 ug/mL) or vancomycin (vancomycin minimum inhibitory concentration (MIC) greater than 2 ug/mL).
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- Patients with necrotizing fasciitis, or deep-seated infections that would require > 2 weeks of antibiotics (e.g., endocarditis, osteomyelitis or septic arthritis).
- Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
- Venous catheter entry site infection.
- Infections involving diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
- Patient with an infected device, even if the device is removed. Examples include infection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, implantable pacemaker or defibrillator, intraaortic balloon pump, left ventricular assist device, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter.
- Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram-positive bacteremia. Note: If a Gram-negative bacteremia develops during the study, or is subsequently found to have been present at Baseline, the patient should be removed from study treatment and receive appropriate antibiotic(s) to treat the Gram-negative bacteremia.
- Patients whose skin infection is the result of having sustained full or partial thickness burns.
- Patients age 3 months to 17 years, with uncomplicated skin infections such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure. Patients birth to < 3 months of age may be enrolled if they have uncomplicated skin infections of sufficient severity to require hospitalization and parenteral antibiotic therapy.
- Patients age 3 months to 17 years: Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study.
- Sickle cell anemia
- Cystic fibrosis
- Anticipated need of antibiotic therapy for longer than 14 days.
- Patients who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI.
- More than 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the skin infection, or patients who are expected to require more than 2 such interventions.
- Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity).
- Immunosuppression/immune deficiency, including hematologic malignancy, recent bone marrow transplant (in post-transplant hospital stay), absolute neutrophil count < 500 cells/mm3, receiving immunosuppressant drugs after organ transplantation, receiving oral steroids ≥ 20 mg prednisolone per day (or equivalent) for > 14 days prior to enrollment, and known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count< 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count.
- Known or suspected hypersensitivity to glycopeptide antibiotics, betalactam agents, aztreonam, or cephalosporins.
- Patients with a rapidly fatal illness, who are not expected to survive for 3 months.
- Positive urine (or serum) pregnancy test at screening (post-menarchal females only) or after admission (prior to dosing).
- Pregnant or nursing females; sexually active females of childbearing potential who are unwilling or unable to use adequate contraceptive precautions. Female patients to have pregnancy testing are those who are at least 10 years old with menarche and/or thelarche (beginning of breast development).
Trial locations and contacts
84 sites in 20 countries.
84 sites in 20 countries
United States15 sites
Children's Healthcare of Atlanta - Ferry Rd /ID# 237003
Atlanta, Georgia, 30342-1605
Duplicate_Children's Hospital Colorado /ID# 237622
Aurora, Colorado, 80045
University of Maryland Medical Center /ID# 234353
Baltimore, Maryland, 21201-1544
Cleveland Clinic Main Campus /ID# 237564
Cleveland, Ohio, 44195
Duke University Medical Center /ID# 234315
Durham, North Carolina, 27705-4410
Duplicate_Children's Mercy Hospital and Clinics /ID# 237800
Kansas City, Missouri, 64108
Southbay Pharma Research /ID# 235700
La Palma, California, 90623
University of California, Los Angeles /ID# 237533
Los Angeles, California, 90095
University of South Alabama /ID# 237446
Mobile, Alabama, 36604-3302
Robert Wood Johnson Univ Hosp /ID# 237862
New Brunswick, New Jersey, 08901
NYU School of Medicine /ID# 236783
New York, New York, 10016
Global Research Holdings LLC /ID# 235747
Panama City, Florida, 32405
Valleywise Health Medical Center /ID# 234343
Phoenix, Arizona, 85008-4973
SUNY Upstate Medical University /ID# 236831
Syracuse, New York, 13210
Tampa General Hospital /ID# 237061
Tampa, Florida, 33606
Bulgaria11 sites
University Multiprofile Hospital for Active Treatment Deva Maria EOOD Burgas /ID# 235965
Bulgas, 8000
MHAT (Multiprofile Hospital for Active Treatment) /ID# 235539
Kozloduy, 3320
UMHAT Dr Georgi Stranski EAD /ID# 237829
Pleven, 5800
UMHAT Dr Georgi Stranski EAD /ID# 237830
Pleven, 5800
Multiprofile Hospital for Active Treatment ( UMHAT) Sveti Georgi EAD Plovdiv /ID# 235487
Plovdiv, 4000
UMHAT Sveti Georgi /ID# 237026
Plovdiv, 4002
UMHAT Kanev /ID# 237809
Rousse, 7002
Medical center 1 Sevlievo /ID# 237470
Sevlievo, 5400
MHATEM N.I.Pirogov Septic Surgery Clinic /ID# 235541
Sofia, 1606
SHAT Hematologic Diseases /ID# 237915
Sofia, 1756
University Multiprofile Hospital for Active Treatment Prof. Dr. Stoyan Kirkovich /ID# 235543
Stara Zagora, 6000
Spain6 sites
Hospital Donostia /ID# 237773
Donostia / San Sebastian, Guipuzcoa, 20014
Hospital Sant Joan de Deu /ID# 236797
Esplugues de Llobregat, Barcelona, 08950
Hospital General Universitario Gregorio Maranon /ID# 236955
Madrid, 28007
Hospital Universitario La Paz /ID# 237775
Madrid, 28046
Complejo Hospitalario Universitario de Santiago /ID# 235512
Santiago de Compostela, A Coruna, 15076
Hospital Universitario y Politecnico La Fe /ID# 237086
Valencia, 46026
Ukraine6 sites
Dnipropetrovsk Regional children's Clinical Hospital /ID# 235558
Dnipro, 49100
Ivano-Frankivsk Pediatric Regional Clinical Hospital /ID# 235556
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76006
PE PMC Acinus, Medical and Diagnostic Center /ID# 237514
Kropyvnytskyi, 25006
Lviv Regional Clinical Hospital /ID# 236921
Lviv, 79010
Ukrainian Medical Stomatological Academy - Children's City Clinical Hospital /ID# 234886
Poltava, 36004
Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 238058
Uzhhorod, 88000
Georgia4 sites
LTD Unimedi Kakheti Batumi Maternal and Child Healthcare Center /ID# 235643
Batumi, 6010
LEPL Tbilisi State Medical University Givi Zhvania Academic Clinic of Pediatry /ID# 235645
Tbilisi, 159
LTD M. Iashvili Children's Central Hospital /ID# 235639
Tbilisi, 159
LTD Unimedi Kakheti Children New Hospital /ID# 235634
Tbilisi, 159
Greece4 sites
University General Hospital Attikon /ID# 237398
Athens, Attica, 12462
Childrens Hospital of Penteli /ID# 235667
Athens, 15236
Papageorgiou General Hospital Thessaloniki /ID# 237505
Stavroupoli (Thessalonikis), Thessaloniki, 55536
General Hospital of Thessaloniki Hippokrateio /ID# 237186
Thessaloniki, 54642
Mexico4 sites
Instituto Nacional de Pediatria /ID# 235506
Coyoacán, Mexico City, 04530
Hospital General Dr. Agustin O'Horan /ID# 235510
Mérida, Yucatán, 97000
Hospital Infantil de Mexico Federico Gomez /ID# 235508
Mexico City, 06720
Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 237597
Monterrey, Nuevo León, 64460
Romania4 sites
Spitalul Clinic de Boli infectioase si Tropicale Dr. Victor Babes /ID# 235610
Bucharest, 030303
Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 235606
Sector 2, Bucharest, 021105
Spitalul Clinic Judeatean Mures /ID# 234728
Târgu Mureş, 540142
Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 235608
Timișoara, Timiș County, 500063
Belarus3 sites
Grodno Regional Infectious Disease Hospital /ID# 235661
Grodno, 230030
Mogilev Regional Children's Hospital /ID# 235657
Mogilev, 212026
Vitebsk Regional Clinical Center for Children /ID# 235659
Vitebsk, 210015
Colombia3 sites
Fundacion Cardioinfantil /Id# 238041
Bogota, Cundinamarca, 111156
Unidad De Investigacion Clinica Universidad De La Sabana /ID# 235566
Chía, Cundinamarca, 25175
Hospital Universitario San Vic /ID# 238117
Medellín, 50010
Guatemala3 sites
Hospital Valle del Sol /ID# 235569
Guatemala City, 1004
Hospital Roosevelt /ID# 235520
Guatemala City, 1011
Hospital del Centro Medico Infectology Department /ID# 235522
Guatemala City, 1016
Latvia3 sites
Daugavpils Regional Hospital /ID# 237022
Daugavpils, LV-5401
Liepaja Regional Hospital /ID# 235650
Liepāja, LV-3414
University Childrens Hospital /ID# 235648
Riga, LV-1004
Lithuania3 sites
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 236947
Kaunas, 50161
Klaipeda Children's Hospital /ID# 235652
Klaipėda, LT- 92144
Duplicate_Children's Hospital Affiliate - Vilnius University Hospital Santariski /ID# 235654
Vilnius, LT-08661
Poland3 sites
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 236920
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-030
Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno /ID# 235518
Poznan, 60-734
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 237112
Warsaw, Masovian Voivodeship, 02-507
Russia3 sites
Smolensk State Medical University /ID# 236996
Smolensk, 214019
Stavropol State Medical University /ID# 236239
Stavropol, 355017
Regional Childrens Hospital /ID# 235560
Vologda, 160022
Brazil2 sites
Duplicate_Hospital Pequeno Princípe /ID# 235629
Curitiba, Paraná, 80250-060
Duplicate_Irmandade Santa Casa de Misericórdia de Porto Alegre /ID# 235627
Porto Alegre, Rio Grande do Sul, 90035-074
Chile2 sites
Hospital de Ninos Dr. Roberto del Rio /ID# 235568
Independencia, 8380418
Hospital El Carmen de Maipú /ID# 235570
Santiago, 8320000
Panama2 sites
Hospital Materno Infantil José Domingo de Obaldía /ID# 235625
Chiriquí, Chiriquí Province
Hospital Del Niño Dr. José Renán Esquivel /ID# 235572
Panama City, 0816-00383
South Africa2 sites
Peermed Clinical Trial Centre /ID# 235514
Kempton Park, Gauteng, 1619
Mzansi Ethical Research Center /ID# 236480
Middelburg, Mpumalanga, 1055
Argentina1 site
Hospital de Ninos Dr. Orlando Alassia /ID# 235562
Santa Fe, 3000
About this study
Official title: A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections
To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.
- Conditions
- Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections, Staphylococcal Skin Infections
- Being tested
- Dalbavancin, Vancomycin, Oxacillin, Flucloxacillin, Cefadroxil
- Keywords
- Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
- Medical subject headings
- Bacterial Infections, Staphylococcal Skin Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalbavancinDrug
Also called Xydalba
Dalbavancin was administered intravenously over 30 (± 5) minutes.
VancomycinDrug
Vancomycin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
OxacillinDrug
Oxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
FlucloxacillinDrug
Flucloxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.
CefadroxilDrug
Cefadroxil was administered orally every 12 hours.
ClindamycinDrug
Clindamycin was administered orally every 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| Dalbavancin single-dose | Experimental | Participants received dalbavancin administered intravenously as follows: birth to < 3 months old and 3 months to < 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to < 3 months were not randomized; all received dalbavancin single-dose. Receives: Drug: Dalbavancin |
| Dalbavancin two-dose | Experimental | Participants received dalbavancin administered intravenously as follows: 3 months to < 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8. Receives: Drug: Dalbavancin |
| Comparator | Active comparator | Participants 3 mos to < 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs. Receives: Drug: Vancomycin; Drug: Oxacillin; Drug: Flucloxacillin; Drug: Cefadroxil; Drug: Clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit
Audiologic testing was to be conducted in at least 20 children < 12 years old, of which at least 9 children were < 2 years old. Audiologic testing conducted on infants (< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Measured: Baseline, Day 28 (± 2 days)
Shift From Baseline in Auditory Brainstem Response Test at TOC Visit
Audiologic testing was to be conducted in at least 20 children < 12 years old, of which at least 9 children were < 2 years old. Audiologic testing conducted on infants (< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Measured: Baseline, Day 28 (± 2 days)
Shift From Baseline in Acoustic Immittance Test at TOC Visit
Audiologic testing was to be conducted in at least 20 children < 12 years old, of which at least 9 children were < 2 years old. Audiologic testing conducted on infants (< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Measured: Baseline, Day 28 (± 2 days)
Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit
Audiologic testing was to be conducted in at least 20 children < 12 years old, of which at least 9 children were < 2 years old. Audiologic testing conducted on infants (< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Measured: Baseline, Day 28 (± 2 days)
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
Bowel flora was evaluated in participants from birth to < 2 years of age by performing polymerase chain reaction (PCR) analysis for Clostridium difficile (C diff) and culture for vancomycin-resistant enterococci (VRE) on a stool specimen or rectal swab. Samples were analyzed at Baseline and at the Test of Cure (TOC) visit.
Measured: Baseline, Day 28 (± 2 days)
Secondary outcomes (24)
Clinical Response at 48-72 Hours
Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy.
Presented for the modified intent-to-treat (mITT) population: all participants who received at least one dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Measured: Baseline, 48-72 hours
Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study.
Improvement: For Cohorts 1-4 and Cohort 5 with ABSSSI, reduction in severity of ≥2, but not all CSSI, when compared with Baseline. For Cohort 5 with sepsis, reduction in severity of ≥1 abnormal clinical and laboratory parameter related to sepsis, when compared with Baseline. For Cohorts 1-4, no additional antibacterial Tx required for disease under study. For Cohort 5, no rescue antibiotics required after ≥48 hours of start of study Tx.
Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection.
Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure.
Presented for the modified intent-to-treat (mITT) population.
Measured: Baseline, Day 14 (± 2 Days)
Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment.
Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Measured: Baseline, Day 14 (± 2 Days)
Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study.
Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection.
Unknown: Extenuating circumstances precluding classification to Cure or Failure.
Presented for the modified intent-to-treat (mITT) population.
Measured: Baseline, Day 28 (± 2 Days)
Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment.
Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Measured: Baseline, Day 28 (± 2 Days)
Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study.
Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection.
Unknown: Extenuating circumstances precluding classification to Cure or Failure.
Presented for the modified intent-to-treat (mITT) population
Measured: Baseline, Day 54 (± 7 days)
Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment.
Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Measured: Baseline, Day 54 (± 7 days)
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, 48-72 hours
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs/symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study.
Improvement: Cohorts 1-4 and Cohort 5 with ABSSSI: reduction in severity of ≥2, but not all CSSI, when compared to Baseline. Cohort 5 with sepsis: reduction in severity of ≥1 abnormal clinical/laboratory parameter related to sepsis, when compared to Baseline. Cohorts 1-4: no additional antibacterial Tx required for disease under study. Cohort 5: no rescue antibiotics required after ≥48 hrs of start of study Tx.
Failure: Persistence/progression of Baseline CSSI after 48 hrs of Tx OR development of new findings consistent with active infection.
Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, Day 14 (± 2 Days)
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, Day 14 (± 2 Days)
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study.
Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection.
Unknown: Extenuating circumstances precluding classification to Cure or Failure.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, Day 28 (± 2 Days)
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, Day 28 (± 2 Days)
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study.
Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection.
Unknown: Extenuating circumstances precluding classification to Cure or Failure.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, Day 54 (± 7 days)
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, Day 54 (± 7 days)
Microbiological Response at 48-72 Hours
Eradication: Source specimen demonstrated absence of the original Baseline pathogen.
Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder.
Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.
Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder.
Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, 48-72 hours
Microbiological Response at the End of Treatment (EOT) Visit
Eradication: Source specimen demonstrated absence of the original Baseline pathogen.
Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement.
Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.
Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure.
Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, Day 14 (± 2 Days)
Microbiological Response at the Test of Cure (TOC) Visit
Eradication: Source specimen demonstrated absence of the original Baseline pathogen.
Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure.
Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.
Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure.
Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, Day 28 (± 2 Days)
Microbiological Response at the Follow-Up Visit
Eradication: Source specimen demonstrated absence of the original Baseline pathogen.
Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure.
Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.
Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure.
Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, Day 54 (± 7 days)
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen.
Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder.
Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.
Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder.
Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.,
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, 48-72 hours
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen.
Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement.
Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.
Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure.
Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, Day 14 (± 2 Days)
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen.
Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure.
Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.
Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure.
Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, Day 28 (± 2 Days)
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen.
Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure.
Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen.
Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure.
Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing.
Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Measured: Baseline, Day 54 (± 7 days)
All-cause Mortality at the Test of Cure (TOC) Visit Among Cohort 5 Participants
All-cause mortality was determined for the participants in Cohort 5 (birth to < 3 months) at the Test of Cure visit.
Measured: Day 28 (± 2 Days)
Concentration of Dalbavancin in Plasma
The population pharmacokinetic (PK) profile of dalbavancin was assessed using a sparse sampling approach. Plasma PK samples were collected from participants receiving dalbavancin treatment (single-dose and two-dose arms) at 30 minutes and at 2 hours (Day 1), at 48-72 hours (Day 3-4), at 168 ± 24 hours (Day 8 ± 1), and at 312 ± 48 hours and analyzed for dalbavancin concentration.
Measured: 30 min (end of infusion on Day 1); 2 hrs after start of IV (Day 1); and 48-72 hrs, 168 hrs, and 312 hrs after start of IV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start30 Mar 2017
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Methicillin-Resistant Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814916
- Sponsor's protocol ID
- DUR001-306
- Other IDs
- 2014-005281-30, 2014
- Status last verified
- Aug 2024
- First submitted
- 8 Jun 2016
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT02814916
- Acronym / sponsor ID
- DUR001-306
- Conditions
- Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections, Staphylococcal Skin Infections
- Keywords
- Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dalbavancin single-dose | Experimental | Drug: DalbavancinParticipants received dalbavancin administered intravenously as follows: birth to < 3 months old and 3 months to < 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to < 3 months were not randomized; all received dalbavancin single-dose. |
| Dalbavancin two-dose | Experimental | Drug: DalbavancinParticipants received dalbavancin administered intravenously as follows: 3 months to < 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8. |
| Comparator | Active comparator | Drug: Vancomycin, Drug: Oxacillin, Drug: Flucloxacillin, Drug: Cefadroxil, Drug: ClindamycinParticipants 3 mos to < 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (36 listed)
- Male or female patients birth to 17 years (inclusive)
- A clinical picture compatible with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) suspected or confirmed to be caused by Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA).
- In addition to local signs of ABSSSI, the patient has at least one of the following:
- Fever, defined as body temperature ≥ 38.4°C (101.2°F) taken orally, ≥ 38.7°C (101.6°F) tympanically, or ≥ 39°C (102.2°F) rectally (core temperature) OR
- Leukocytosis (WBC > 10,000 mm3) or leukopenia (WBC < 2,000 mm3) or left shift of >10% band neutrophils
Key exclusion criteria (26 listed)
- Patients age 3 months to 17 years: Clinically significant renal impairment, defined as calculated creatinine clearance of less than 30 mL/min. (calculated by the Schwartz "bedside" formula). Patients birth to < 3 months of age: Moderate or severe renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal (× ULN) for age OR urine output < 0.5 mL/kg/h (measured over at least 8 hours prior to dosing) OR requirement for dialysis.
- Clinically significant hepatic impairment, defined as serum bilirubin or alkaline phosphatase greater than 2 times the upper limits of normal (ULN) for age, and/or serum aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal (ULN) for age.
- Treatment with an investigational drug within 30 days preceding the first dose of study medication.
- Patients with sustained shock defined as systolic blood pressure < 90 mm Hg in children ≥ 10 years old, < 70 mm Hg + [2 x age in years] in children 1 to <10 years, or < 70 mmHg in infants 3 to <12 months old for more than 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure.
- More than 24 hours of any systemic antibacterial therapy within 96 hours before randomization. EXCEPTION: Microbiological or clinical treatment failure with a systemic antibiotic other than IV study drug that was administered for at least 48 hours. Failure must be confirmed by either a microbiological laboratory report or documented worsening clinical signs or symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DalbavancinAlso: XydalbaDalbavancin was administered intravenously over 30 (± 5) minutes. | Drug | Dalbavancin single-dose, Dalbavancin two-dose |
| VancomycinVancomycin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours. | Drug | Comparator |
| OxacillinOxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours. | Drug | Comparator |
| FlucloxacillinFlucloxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours. | Drug | Comparator |
| CefadroxilCefadroxil was administered orally every 12 hours. | Drug | Comparator |
| ClindamycinClindamycin was administered orally every 8 hours. | Drug | Comparator |
Primary outcome
Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit
Time frame: Baseline, Day 28 (± 2 days)
Audiologic testing was to be conducted in at least 20 children < 12 years old, of which at least 9 children were < 2 years old. Audiologic testing conducted on infants (< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Shift From Baseline in Auditory Brainstem Response Test at TOC Visit
Time frame: Baseline, Day 28 (± 2 days)
Audiologic testing was to be conducted in at least 20 children < 12 years old, of which at least 9 children were < 2 years old. Audiologic testing conducted on infants (< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Shift From Baseline in Acoustic Immittance Test at TOC Visit
Time frame: Baseline, Day 28 (± 2 days)
Audiologic testing was to be conducted in at least 20 children < 12 years old, of which at least 9 children were < 2 years old. Audiologic testing conducted on infants (< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit
Time frame: Baseline, Day 28 (± 2 days)
Audiologic testing was to be conducted in at least 20 children < 12 years old, of which at least 9 children were < 2 years old. Audiologic testing conducted on infants (< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
Time frame: Baseline, Day 28 (± 2 days)
Bowel flora was evaluated in participants from birth to < 2 years of age by performing polymerase chain reaction (PCR) analysis for Clostridium difficile (C diff) and culture for vancomycin-resistant enterococci (VRE) on a stool specimen or rectal swab. Samples were analyzed at Baseline and at the Test of Cure (TOC) visit.
24 secondary outcomes
Clinical Response at 48-72 Hours
Time frame: Baseline, 48-72 hours
Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
Time frame: Baseline, Day 14 (± 2 Days)
Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
Time frame: Baseline, Day 14 (± 2 Days)
Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
Time frame: Baseline, Day 28 (± 2 Days)
Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
Time frame: Baseline, Day 28 (± 2 Days)
Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome)
Time frame: Baseline, Day 54 (± 7 days)
Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor)
Time frame: Baseline, Day 54 (± 7 days)
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
Time frame: Baseline, 48-72 hours
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
Time frame: Baseline, Day 14 (± 2 Days)
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
Time frame: Baseline, Day 14 (± 2 Days)
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
Time frame: Baseline, Day 28 (± 2 Days)
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
Time frame: Baseline, Day 28 (± 2 Days)
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
Time frame: Baseline, Day 54 (± 7 days)
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
Time frame: Baseline, Day 54 (± 7 days)
Microbiological Response at 48-72 Hours
Time frame: Baseline, 48-72 hours
Microbiological Response at the End of Treatment (EOT) Visit
Time frame: Baseline, Day 14 (± 2 Days)
Microbiological Response at the Test of Cure (TOC) Visit
Time frame: Baseline, Day 28 (± 2 Days)
Microbiological Response at the Follow-Up Visit
Time frame: Baseline, Day 54 (± 7 days)
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
Time frame: Baseline, 48-72 hours
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
Time frame: Baseline, Day 14 (± 2 Days)
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
Time frame: Baseline, Day 28 (± 2 Days)
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
Time frame: Baseline, Day 54 (± 7 days)
All-cause Mortality at the Test of Cure (TOC) Visit Among Cohort 5 Participants
Time frame: Day 28 (± 2 Days)
Concentration of Dalbavancin in Plasma
Time frame: 30 min (end of infusion on Day 1); 2 hrs after start of IV (Day 1); and 48-72 hrs, 168 hrs, and 312 hrs after start of IV
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related infoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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Not yet recruitingPhase 2
A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization
Clostridium Infections, Methicillin-resistant Staphylococcus Aureus (MRSA)
RecruitingPhase 4
Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
Methicillin Resistant Staphylococcus Aureus, Osteomyelitis Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
84 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dalbavancin, Vancomycin and Oxacillin in people with Methicillin-Resistant Staphylococcus Aureus and Bacterial Infections, run by AbbVie at 84 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States, Bulgaria, Spain, Ukraine, Georgia and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit (time frame: Baseline, Day 28 (± 2 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.