OsteomyelitisPhase 3AHOMNCT02344511
Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis
A Phase 3 study testing Dalbavancin and cefazolin, nafcillin, oxacillin or vancomycin in people with Osteomyelitis, run by Durata Therapeutics International BV (an Affiliate of Actavis, Inc.).
Trial summary
Dalbavancin for Pediatric Osteomyelitis Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Osteomyelitis
- What is being tested?
- Dalbavancin and cefazolin, nafcillin, oxacillin or vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Apr 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female 2-16 yrs
- diagnosis of Acute Hematogenous Osteomyelitis (AHOM) of the long bones (ulna, radius, femur, tibia) defined by the following clinical signs and symptoms (< 2 weeks in duration; multiple sites of infection within long bones):
- Limb abnormality: Pain, point tenderness upon palpation, motion restriction, loss of function
- Magnetic resonance imaging (MRI) -OR- Gram-positive cocci documented on a Gram-stain from a bone specimen or from blood cultures.
- Elevated C-Reactive Protein (CRP)
- informed consent
- willing and able to comply with the study protocol
- Life Expectancy with appropriate antibiotic therapy and thru study duration
Who cannot join
- Treatment with an investigational drug within 30 days preceding the first dose of study medication.
- Receipt of > 24 hours of potentially effective intravenous antibacterial therapy for AHOM within 96 hours before randomization, unless the pathogen isolated was documented to be Methicillin resistant Staphylococcus aureus (MRSA) that was resistant to the administered antibiotic.
- Evidence of subacute or chronic osteomyelitis including: symptoms > 2 weeks in duration
- AHOM of non-long bones (e.g., pelvis or spine).
- Extraosseous findings such as: subperiosteal abscess, pyomyositis, venous thrombosis, or pulmonary embolism.
- Previous history of septic arthritis or osteomyelitis.
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- Major trauma, open-fracture, puncture wound of the foot, post-operative osteomyelitis, foreign body in or adjacent to affected bone or joint, or other iatrogenic bone or joint infections present at the site of infection.
- Septic arthritis that is non-contiguous to osteomyelitis
- Immunosuppression/immune deficiency
- Evidence of Gram-negative bacteria by gram stain in the absence of Gram-positive organisms; fungus or mycobacteria at baseline.
- Gram-negative bacteremia, even in the presence of gram-positive infection or gram-positive bacteremia.
- A history of oral ulcers preceding the onset of musculoskeletal findings, recent gastrointestinal surgery (within 2 months)
- Infection due to an organism known prior to study entry to be not susceptible to dalbavancin (dalbavancin mean inhibitory concentration > 0.12 µg/mL) or vancomycin (vancomycin mean inhibitory concentration (MIC) > 2 μg/mL).
- Concomitant systemic antibacterial therapy for Gram-positive infections (eg. Rifampin, gentamicin).
- 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.
- hypersensitivity to glycopeptide antibiotics.
- not expected to survive for 3 months.
- Positive urine (or serum) pregnancy test
- Women of Child Bearing Potential who are unwilling or unable to use adequate contraceptive precautions.
- Other severe acute or chronic medical or psychiatric condition would make the patient inappropriate for entry into this study.
- Unwilling or unable to follow study procedures.
About this study
Official title: A Phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be Due to Gram-Positive Organisms
Dalbavancin for Pediatric Osteomyelitis
Read the detailed description
A Phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be due to Gram-Positive Organisms.
- Conditions
- Osteomyelitis
- Being tested
- Dalbavancin, cefazolin, nafcillin, oxacillin or vancomycin
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalbavancinDrug
Also called Dalvance
Drug
cefazolin, nafcillin, oxacillin or vancomycinDrug
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Dalbavancin | Experimental | Patients with Creatine Clearance (CrCl) greater than 30 mL/min and patients receiving regular hemodialysis or peritoneal dialysis will receive 15 mg/kg Intravenous (IV) dalbavancin over 30 (+/- 5) minutes on Day 1 and on Day 8, not to exceed 1500 mg per administration in children at least 12 years and not to exceed 1000 mg per administration in children less than 12 years of age.
• Patients with CrCl < 30 mL/min who are not receiving regular hemodialysis or peritoneal dialysis will receive 10 mg/kg IV dalbavancin over 30 (+/- 5) minutes on Day 1 and on Day 8, not to exceed 1000 mg per administration in children at least 12 years and not to exceed 750 mg per administration in children less than 12 years of age.
Additionally, subjects randomized to the dalbavancin group will receive an IV placebo infusion at times corresponding to comparator group dosage times for the first eight days. Receives: Drug: Dalbavancin |
| 4 Comparators | Active comparator | cefazolin, oxacillin, nafcillin or vancomycin according to the commercial label
Patients with normal renal function will receive either vancomycin 15 mg/kg/dose, infused over 60 (+/- 10) minutes, every 6 hours (+/- 1 hour) not to exceed a daily total dose of 4000 mg, with dose adjustment based on local standard of care to achieve serum trough concentrations of 10 μg/mL to 20 μg/mL; or cefazolin 25 mg/kg/dose, infused over 60 (+/- 10) minutes, every 6 hours (+/- 1 hour); or nafcillin or oxacillin 50 mg/kg/dose, infused over 60 (+/- 10) minutes, every 6 hours (+/- 1 hour). Receives: Drug: cefazolin, nafcillin, oxacillin or vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with clinical improvement at Day 8
Measured: Day 8
Secondary outcomes (4)
Number of clinical responders
Measured: Day 8
Average reduction in C-reactive Protein (CRP) relative to the highest value
Measured: Day 8
Number of clinical responders by pathogen
Measured: Day 8
Number of Participants with Adverse Events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startMar 2016
- Primary completionOct 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durata Therapeutics International BV (an Affiliate of Actavis, Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alena Jamdourek, MD, Study director, Durata Therapeutics Inc., an affiliate of Allergan plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344511
- Sponsor's protocol ID
- DUR001-304
- Acronym
- AHOM
- Status last verified
- Sep 2016
- First submitted
- 10 Jan 2015
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be Due to Gram-Positive Organisms
- ClinicalTrials.gov ID
- NCT02344511
- Acronym / sponsor ID
- AHOM / DUR001-304
- Conditions
- Osteomyelitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Durata Therapeutics International BV (an Affiliate of Actavis, Inc.)Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dalbavancin for Pediatric Osteomyelitis
Detailed description
A Phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be due to Gram-Positive Organisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dalbavancin | Experimental | Drug: DalbavancinPatients with Creatine Clearance (CrCl) greater than 30 mL/min and patients receiving regular hemodialysis or peritoneal dialysis will receive 15 mg/kg Intravenous (IV) dalbavancin over 30 (+/- 5) minutes on Day 1 and on Day 8, not to exceed 1500 mg per administration in children at least 12 years and not to exceed 1000 mg per administration in children less than 12 years of age. • Patients with CrCl < 30 mL/min who are not receiving regular hemodialysis or peritoneal dialysis will receive 10 mg/kg IV dalbavancin over 30 (+/- 5) minutes on Day 1 and on Day 8, not to exceed 1000 mg per administration in children at least 12 years and not to exceed 750 mg per administration in children less than 12 years of age. Additionally, subjects randomized to the dalbavancin group will receive an IV placebo infusion at times corresponding to comparator group dosage times for the first eight days. |
| 4 Comparators | Active comparator | Drug: cefazolin, nafcillin, oxacillin or vancomycincefazolin, oxacillin, nafcillin or vancomycin according to the commercial label Patients with normal renal function will receive either vancomycin 15 mg/kg/dose, infused over 60 (+/- 10) minutes, every 6 hours (+/- 1 hour) not to exceed a daily total dose of 4000 mg, with dose adjustment based on local standard of care to achieve serum trough concentrations of 10 μg/mL to 20 μg/mL; or cefazolin 25 mg/kg/dose, infused over 60 (+/- 10) minutes, every 6 hours (+/- 1 hour); or nafcillin or oxacillin 50 mg/kg/dose, infused over 60 (+/- 10) minutes, every 6 hours (+/- 1 hour). |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male or female 2-16 yrs
- diagnosis of Acute Hematogenous Osteomyelitis (AHOM) of the long bones (ulna, radius, femur, tibia) defined by the following clinical signs and symptoms (< 2 weeks in duration; multiple sites of infection within long bones):
- Limb abnormality: Pain, point tenderness upon palpation, motion restriction, loss of function
- Magnetic resonance imaging (MRI) -OR- Gram-positive cocci documented on a Gram-stain from a bone specimen or from blood cultures.
- Elevated C-Reactive Protein (CRP)
Key exclusion criteria (23 listed)
- Treatment with an investigational drug within 30 days preceding the first dose of study medication.
- Receipt of > 24 hours of potentially effective intravenous antibacterial therapy for AHOM within 96 hours before randomization, unless the pathogen isolated was documented to be Methicillin resistant Staphylococcus aureus (MRSA) that was resistant to the administered antibiotic.
- Evidence of subacute or chronic osteomyelitis including: symptoms > 2 weeks in duration
- AHOM of non-long bones (e.g., pelvis or spine).
- Extraosseous findings such as: subperiosteal abscess, pyomyositis, venous thrombosis, or pulmonary embolism.
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: DalvanceDrug | Drug | Dalbavancin |
| cefazolin, nafcillin, oxacillin or vancomycinStandard of Care | Drug | 4 Comparators |
Primary outcome
Number of patients with clinical improvement at Day 8
Time frame: Day 8
4 secondary outcomes
Number of clinical responders
Time frame: Day 8
Average reduction in C-reactive Protein (CRP) relative to the highest value
Time frame: Day 8
Number of clinical responders by pathogen
Time frame: Day 8
Number of Participants with Adverse Events
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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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.
Alena Jamdourek, MD study director
Durata Therapeutics Inc., an affiliate of Allergan plc
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dalbavancin and cefazolin, nafcillin, oxacillin or vancomycin in people with Osteomyelitis, run by Durata Therapeutics International BV (an Affiliate of Actavis, Inc.).
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 8 inclusion and 23 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: withdrawn, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of patients with clinical improvement at Day 8 (time frame: Day 8). 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 23 Sep 2016.