AbscessPhase 3NCT01431339
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
A Phase 3 study testing IV Dalbavancin and Vancomycin/Linezolid in people with Abscess and Wound Infection, run by Durata Therapeutics Inc., an affiliate of Allergan plc at 137 sites in 14 countries.
Trial summary
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial skin or skin structure infections. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Abscess, Wound Infection, Surgical Site Infection
- What is being tested?
- IV Dalbavancin and Vancomycin/Linezolid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 739 participants
- Where
- 137 sitesin 14 countries
- Study dates
- Jul 2011to Dec 2012
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 18 - 85 years of age.
- Signed and dated informed consent document.
- Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria.
- At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic sign of infection.
- Requires a minimum of 3 days of IV therapy.
- Patient willing and able to comply with study procedures.
Who cannot join
- Patients presenting with any of the following:
- A contra-indication to any required study drug.
- Pregnant or nursing females.
- Sustained shock.
- Participation in another study of an investigational drug or device within 30 days.
- Receipt of a systemically or topically administered antibiotic within 14 days prior to randomization, except receipt of a single dose of a short-acting antibacterial drug 3 or more days prior to randomization.
Show all 28Show fewer
- Infection due to a dalbavancin or vancomycin-resistant organism.
- Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis, and/or endovascular infection.
- Exclusively gram-negative bacterial or a fungal ABSSSI.
- Venous catheter infection.
- Infection of a diabetic foot ulcer or a decubitus ulcer.
- Device-related infections.
- Gram-negative bacteremia.
- Infected burns.
- Infected limb with critical ischemia.
- Superficial/simple skin and skin structure infections.
- Concomitant condition requiring non-study antibacterial therapy.
- ABSSSI requiring therapy for longer than 14 days.
- Adjunctive therapy with hyperbaric oxygen.
- More than 2 surgical interventions for ABSSSI anticipated.
- Chronic inflammatory condition precluding assessment of clinical response.
- Absolute neutrophil count < 500 cells/mm3.
- Human immunodeficiency virus (HIV) infection with a CD4 cell count < 200 cells/mm3.
- Recent bone marrow transplant, > 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
- Regular, chronic antipyretic use in patients unable to modify during the first three days of study drug therapy.
- Life expectancy less than 3 months.
- Conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
- Prior participation in the study.
Trial locations and contacts
137 sites in 14 countries.
137 sites in 14 countries
United States30 sites
Durata Clinical Site
Anaheim, California, 92804
Durata Clinical Site
Augusta, Georgia, 30901
Durata Study Site
Austin, Texas, 78701
Durata Clinical Site
Austin, Texas, 78752
Durata Study Site
Baton Rouge, Louisiana, 70809
Durata Clinical Site
Boyton Beach, Florida, 33435
Durata Clinical Site
Buena Park, California, 90620
Durata Clinical Site
Chicago, Illinois, 60637
Durata Study Site
Chula Vista, California, 91911
Durata Study Site
Columbus, Georgia, 31904
Durata Clinical Site
Fort Meyers, Florida, 33966
Durata Clinical Site
Houston, Texas, 77055
Durata Study Site
Las Vegas, Nevada, 89109
Durata Clinical Site
Long Beach, California, 90813
Durata Study Site
Los Angeles, California, 90015
Durata Clinical Site
Miami, Florida, 33015
Durata Study Site
Middleton, Wisconsin, 53562
Durata Clinical Site
Montgomery, Alabama, 36106
Durata Study Site
New Orleans, Louisiana, 70112
Durata Study Site
Norwalk, California, 90650
Durata Study Site
Orlando, Florida, 32837
Durata Study Site
Oxnard, California, 93030
Durata Study Site
Philadelphia, Pennsylvania, 19103
Durata Study Site
Richmond, Texas, 77469
Durata Clinical Site
Saint Cloud, Florida, 34769
Durata Study SIte
San Diego, California, 92120
Durata Study Site
Shreveport, Louisiana, 71101
Durata Study Site
Springfield, Ohio, 45502
Durata Study Site
Stockton, California, 95204
Durata Study Site
Zachary, Louisiana, 70791
South Korea13 sites
Durata Clinical Site
Ansan, 425-707
Durata Study Site
Daejeon, 301721
Durata Study Site
Gwangju, 501-757
Durata Clinical Site
Incheon, 405-760
Durata Clinical Site
Jung Gu, Daegu, 700-721
Durata Clinical Site
Kangwon-do, 220-71
Durata Study Site
Seoul, 133-791
Durata Clinical Site
Seoul, 134-701
Durata Study Site
Seoul, 134-701
Durata Study Site
Seoul, 135-710
Durata Clinical Site
Seoul, 136-705
Durata Study Site
Seoul, 138-736
Durata Clinical Site
Seoul, 152-703
Ukraine13 sites
Durata Study Site
Cherkasy, 18009
Durata Study Site
Dnipropetrovsk, 49005
Durata Study Site
Donetsk, 83099
Durata Clinical Site
Ivano-Frankivsk, 76014
Durata Study Site
Ivano-Frankivsk, 76014
Durata Study Site
Ivano-Frankivsk, 76025
Durata Study Site
Kharkiv, 61058
Durata Clinical Site
Kyiv, 02666
Durata Study Site
Kyiv, 02666
Durata Study Site
Lviv, 79013
Durata Study Site
Lviv, 79059
Durata Study Site
Uzhhorod, 88000
Durata Study Site
Zaporizhia, 69032
South Africa12 sites
Durata Clinical Site
Gauteng, Pretoria, 0001
Durata Study Site
Gauteng, Soweto, 2013
Durata Study Site
Johannesburg, 1500
Durata Study Site
KwaZulu, Durban, 4037
Durata Study Site
KwaZulu-Natal, Ladysmieth, 3370
Durata Study Site
Mpekweni, Paarl, 7646
Durata Study Site
Mpumalanga, Middleburg, 1055
Durata Study Site
Port Elizabeth, 6014
Durata Study Site
Port Elizabeth, 6070
Durata Clinical Site
Pretoria, 0084
Durata Study Site
Thabazimbi, 0380
Durata Study Site
Western Cape, Paarl, 7646
Russia11 sites
Durata Study Site
Moscow, 111539
Durata Clinical Site
Moscow, 115280
Durata Study Site
Petrozavodsk, 18519
Durata Clinical Site
Saint Petersburg, 198099
Durata Clinical Site
Smolensk, 214018
Durata Study Site
Tomsk
Durata Clinical Site
Tver', 170036
Durata Clinical Site
Volgograd, 400138
Durata Clinical Site
Vsevolozhsk, Leningradskaya Oblast', 188640
Durata Study Site
Vsevolozhsk, Leningradskaya Oblast', 188864
Durata Clinical Site
Yaroslavl, 150003
Romania10 sites
Durata Study Site
Bucharest, 010713
Durata Clinical Site
Bucharest, 010825
Durata Study Site
Bucharest, 011461
Durata Clinical Trial
Bucharest, 042122
Durata Study Site
Bucharest, 75622
Durata Clinical Site
Burcharest, 020125
Durata Study Site
Cluj-Napoca, 400006
Durata Study Site
Constanța, 900709
Durata Study Site
Târgu Mureş, 540072
Durata Clinical Site
Timișoara, 300736
Bulgaria7 sites
Durata Study Site
Pleven, 5800
Durata Study Site
Plovdiv, 4000
Durata Study Site
Sevlievo, 5400
Durata Study Site
Sofia, 1000
Durata Study Site
Sofia, 1407
Durata Study Site
Sofia, 1431
Durata Study Site
Sofia, 1606
Hungary7 sites
Durata Study Site
Budapest, H-1081
Durata Clinical Site
Budapest
Durata Study Site
Debrecen, H-4043
Durata Clinical Site
Kaposvár, H-7400
Durata Clinical SIte
Pécs, H-7624
Durata Clinical Site
Szeged, H-6720
Durata Study Site
Veszprém, H-8200
Israel7 sites
Durata Clinical Site
Haifa, 31906
Durata Study Site
Jerusalem, 91120
Durata Clinical Site
Kfar Saba, 44281
Durata Clinical Site
Petah Tikva, 49100
Durata Study Site
Petah Tikva, 49100
Durata Clinical Site
Ramat Gan, 52621
Durata Study Site
Tel Aviv, 64239
Taiwan7 sites
Durata Study Site
Kaohsiung City, 813
Durata Study Site
Kaohsiung City, ROC 807
Durata Clinical Site
Taichung, 40447
Durata Study Site
Tainan, Fujian, 70403
Durata Clinical Site
Taipai
Durata Study Site
Taipei, 10002
Durata Study Site
Yung Kang City, 71044
Latvia6 sites
Durata Clinical Site
Daugavpils, LV-5417
Durata Clinical Site
Liepāja, LV-3414
Durata Study Site
Rēzekne, LV-4600
Durata Study Site
Riga, LV-1001
Durata Clinical Site
Riga, LV-1002
Durata Clinical Site
Ventspils, LV-3601
Estonia5 sites
Durata Study Site
Kohtla-Järve, 30322
Durata Clinical Site
Kohtla-Järve
Durata Clinical Site
Tallinn, 10136
Durata Clinical Site
Tallinn, 13419
Durata Study Site
Tartu, 51014
Lithuania5 sites
Durata Clinical Site
Kaunas, LT-45130
Durata Clinical Site
Kauno M. Sav, LT-47144
Durata Clinical Site
Klaipėda, LT-76231
Durata Clinical Site
Šiauliai, LT-76231
Durata Clinical Trial
Vilnius, LT-10207
Slovakia4 sites
Durata Clinical Site
Banská Bystrica, 975 17
Durata Clinical Site
Levice, 934 01
Durata Clinical Site
Nitra, 950 01
Durata Clinical Site
Svidník, 089 01
About this study
Official title: A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Dalbavancin to a Comparator Regimen (Vancomycin and Linezolid) for the Treatment of Acute Bacterial Skin and Skin Structure Infections
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial skin or skin structure infections.
- Conditions
- Abscess, Wound Infection, Surgical Site Infection, Cellulitis
- Being tested
- IV Dalbavancin, Vancomycin/Linezolid
- Medical subject headings
- Abscess, Wound Infection, Surgical Wound Infection, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV DalbavancinDrug
IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
Vancomycin/LinezolidDrug
IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin with possible switch to oral linezolid | Active comparator | Not described Receives: Drug: Vancomycin/Linezolid |
| Dalbavancin | Experimental | Not described Receives: Drug: IV Dalbavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Clinical Efficacy
Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature
Measured: After 48-72 hours of therapy
Secondary outcomes (3)
Clinical Status
Compare the clinical efficacy at end of treatment visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of other therapy
Measured: End of Treatment Visit (Day 14-15)
>= 20% Reduction in Lesion Area
Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size
Measured: 48-72 hours after the initiation of study therapy
Clinical Status
Compare the clinical efficacy at the short term follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs temperature and receipt of other therapy
Measured: Follow-Up Visit (day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2012
- Study completionDec 2012
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AbscessStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 739 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Dunne, MD, Study director, Durata Therapeutics Inc., an affiliate of Allergan plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431339
- Sponsor's protocol ID
- DUR001-302
- Status last verified
- Dec 2013
- First submitted
- 8 Sep 2011
- Last updated
- 12 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):423-434. doi: 10.1007/s40121-021-00568-7. Epub 2021 Dec 14.
PubMed 34905144Boucher HW, Wilcox M, Talbot GH, Puttagunta S, Das AF, Dunne MW. Once-weekly dalbavancin versus daily conventional therapy for skin infection. N Engl J Med. 2014 Jun 5;370(23):2169-79. doi: 10.1056/NEJMoa1310480.
PubMed 24897082
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Dalbavancin to a Comparator Regimen (Vancomycin and Linezolid) for the Treatment of Acute Bacterial Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT01431339
- Acronym / sponsor ID
- DUR001-302
- Conditions
- Abscess, Wound Infection, Surgical Site Infection, Cellulitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 739 participants (actual)
- Lead sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Posted 12 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial skin or skin structure infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin with possible switch to oral linezolid | Active comparator | Drug: Vancomycin/Linezolid |
| Dalbavancin | Experimental | Drug: IV Dalbavancin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients 18 - 85 years of age.
- Signed and dated informed consent document.
- Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria.
- At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic sign of infection.
- Requires a minimum of 3 days of IV therapy.
Key exclusion criteria (28 listed)
- A contra-indication to any required study drug.
- Pregnant or nursing females.
- Sustained shock.
- Participation in another study of an investigational drug or device within 30 days.
- Receipt of a systemically or topically administered antibiotic within 14 days prior to randomization, except receipt of a single dose of a short-acting antibacterial drug 3 or more days prior to randomization.
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 |
|---|---|---|
| IV DalbavancinIV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8 | Drug | Dalbavancin |
| Vancomycin/LinezolidIV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days | Drug | Vancomycin with possible switch to oral linezolid |
Primary outcome
Early Clinical Efficacy
Time frame: After 48-72 hours of therapy
Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature
3 secondary outcomes
Clinical Status
Time frame: End of Treatment Visit (Day 14-15)
>= 20% Reduction in Lesion Area
Time frame: 48-72 hours after the initiation of study therapy
Clinical Status
Time frame: Follow-Up Visit (day 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34905144Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):423-434. doi: 10.1007/s40121-021-00568-7. Epub 2021 Dec 14.
- Derived from this study: PubMed 24897082Boucher HW, Wilcox M, Talbot GH, Puttagunta S, Das AF, Dunne MW. Once-weekly dalbavancin versus daily conventional therapy for skin infection. N Engl J Med. 2014 Jun 5;370(23):2169-79. doi: 10.1056/NEJMoa1310480.
Related trials for Abscess
Not yet recruitingPhase 2
Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses
Abscess
RecruitingPhase 4
A Single Dose of Intravenous Penicillin as an Adjunct to Oral Penicillin in the Treatment of Acute Tonsillitis, Peritonsillar Phlegmon, and Peritonsillar Abscess
Acute Tonsillitis, Peritonsillar Abscess
RecruitingPhase 1
A Study of Amicidin-β Topical Solution for Patients With a Contaminated or Infected Surgical or Traumatic Wound or Cutaneous Abscess
Surgical Wound Infection, Traumatic Wound Infection
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
RecruitingPhase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
Metastatic Breast Cancer, Leptomeningeal Disease
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.
Michael Dunne, MD study director
Durata Therapeutics Inc., an affiliate of Allergan plc
137 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IV Dalbavancin and Vancomycin/Linezolid in people with Abscess and Wound Infection, run by Durata Therapeutics Inc., an affiliate of Allergan plc at 137 sites in 14 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 6 inclusion and 28 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 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 137 sites in United States, South Korea, Ukraine, South Africa, Russia and 9 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 12 Feb 2014). 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?
Early Clinical Efficacy (time frame: After 48-72 hours of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01431339, which also lists 2 linked publications.
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 12 Feb 2014.