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NCT01339091 · 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 of Surgical Site Infection and Abscess, sponsored by Durata Therapeutics Inc., an affiliate of Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 573
- Enrollment target
- 20
- Study locations
NCT01339091: Completed Phase 3 study of Surgical Site Infection and Abscess, sponsored by Durata Therapeutics Inc., an affiliate of Allergan.
NCT01339091 is a Phase 3 study of Surgical Site Infection and Abscess that has completed, run by Durata Therapeutics Inc., an affiliate of Allergan. The registered enrollment target is 573 participants, roughly in line with the 546-participant average among 25 other Surgical Site Infection trials with a reported enrollment target. The trial reports 20 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01339091, a Phase 3 study of Surgical Site Infection and Abscess, has completed, sponsored by Durata Therapeutics Inc., an affiliate of Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 573 participants
- Enrollment target
- 20
- Study locations
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 proven gram-positive bacterial skin or skin structure infection.
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
Conditions Studied
Interventions
- DRUG Dalbavancin
- DRUG Vancomycin / Linezolid
Study Locations (20)
California
- Durata Study Site - Anaheim
- Durata Study Site - Azusa
- Durata Study Site - Bellflower
- Durata Study Site - Buena Park
- Durata Study Site - Carmel
- Durata Study Site - Chula Vista
- Durata Study Site - Covina
- Durata Study Site - Fountain Valley
- Durata Study Site - La Mesa
- Durata Study Site - Long Beach
- Durata Study Site - Los Alamitos
- Durata Study Site - Los Angeles
- Durata Study Site - Oceanside
- Durata Study Site - Palm Desert
- Durata Study Site - Pasadena
- Durata Study Site - Sacramento
- Durata Study Site - San Diego
- Durata Study Site - Santa Ana
- Durata Study Site - Sylmar
- Durata Study Site - Torrance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 573 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01339091 record still lists
NCT01339091 is an interventional study that assigns participants to a tested intervention. The registered 573 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 546-participant average among 25 other Surgical Site Infection trials with a reported enrollment target.
The record links to 4 conditions, with Surgical Site Infection appearing as the primary indexed condition, and to 2 interventions - of which Dalbavancin is the first listed.
NCT01339091 names 20 study sites across 1 states, led by California.
Frequently Asked Questions
What is clinical trial NCT01339091 about?
NCT01339091 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 proven gram-positive bacterial skin or skin structure infect...
What is the current status of trial NCT01339091?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 573 participants. The study started on 2011-03. Estimated completion is 2012-11.
What conditions does trial NCT01339091 study?
This clinical trial studies the following conditions: Surgical Site Infection, Abscess, Cellulitis, Wound Infection.
What interventions are being tested in trial NCT01339091?
The interventions under investigation include: Dalbavancin (DRUG), Vancomycin / Linezolid (DRUG).
Who is sponsoring clinical trial NCT01339091?
This trial is sponsored by Durata Therapeutics Inc., an affiliate of Allergan, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01339091 being conducted?
This trial has 20 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Surgical Site Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01339091's enrollment target sits among peer trials
573 9th of 25 higher than 17 of 25 other Surgical Site Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgical Site Infection 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.
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