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NCT01431339 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
A Phase 3 study, sponsored by Durata Therapeutics Inc., an affiliate of Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 739
- Enrollment target
NCT01431339: Completed Phase 3 study, sponsored by Durata Therapeutics Inc., an affiliate of Allergan.
NCT01431339 is a Phase 3 study that has completed, run by Durata Therapeutics Inc., an affiliate of Allergan. The registered enrollment target is 739 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01431339, a Phase 3 study, has completed, sponsored by Durata Therapeutics Inc., an affiliate of Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 739 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG IV Dalbavancin
- DRUG Vancomycin/Linezolid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 739 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT01431339 record still lists
NCT01431339 is an interventional study that assigns participants to a tested intervention. The registered 739 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which IV Dalbavancin is the first listed.
NCT01431339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01431339 about?
NCT01431339 is a clinical study titled "Efficacy and Safety of Dalbavancin 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 infect...
What is the current status of trial NCT01431339?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 739 participants. The study started on 2011-07. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01431339?
The interventions under investigation include: IV Dalbavancin (DRUG), Vancomycin/Linezolid (DRUG).
Who is sponsoring clinical trial NCT01431339?
This trial is sponsored by Durata Therapeutics Inc., an affiliate of Allergan, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01431339's enrollment target sits among peer trials
739 478th of 2000 higher than 1,522 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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