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NCT00061633 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
A Phase 2 study of Burns and Ulcer, sponsored by Cumberland Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 169
- Enrollment target
- 1
- Study location
NCT00061633: Completed Phase 2 study of Burns and Ulcer, sponsored by Cumberland Pharmaceuticals.
NCT00061633 is a Phase 2 study of Burns and Ulcer that has completed, run by Cumberland Pharmaceuticals. The registered enrollment target is 169 participants, above the 79-participant average among 36 other Burns trials with a reported enrollment target (114% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00061633, a Phase 2 study of Burns and Ulcer, has completed, sponsored by Cumberland Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 169 participants
- Enrollment target
- 1
- Study location
Study Summary
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.
Primary Outcome
* Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary. * Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to the Test-of-Cure (TOC) visit. * Indete
Conditions Studied
Interventions
- DRUG Telavancin
- DRUG Vancomycin or antistaphylococcal penicillin
Study Locations (1)
California
- eStudy Site, 3450 Bonita Road, Ste 201 - Chula Vista
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2003-06 |
| Est. Completion | 2004-01 |
| Phase | Phase 2 |
What the finished NCT00061633 record still lists
NCT00061633 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, above the 79-participant average among 36 other Burns trials with a reported enrollment target (114% higher).
The record links to 6 conditions, with Burns appearing as the primary indexed condition, and to 2 interventions - of which Telavancin is the first listed.
NCT00061633 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00061633 about?
NCT00061633 is a clinical study titled "Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)". Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether thi...
What is the current status of trial NCT00061633?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2003-06. Estimated completion is 2004-01.
What conditions does trial NCT00061633 study?
This clinical trial studies the following conditions: Burns, Ulcer, Abscess, Cellulitis, Infections, Gram-positive Bacterial.
What interventions are being tested in trial NCT00061633?
The interventions under investigation include: Telavancin (DRUG), Vancomycin or antistaphylococcal penicillin (DRUG).
Who is sponsoring clinical trial NCT00061633?
This trial is sponsored by Cumberland Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00061633 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Burns
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 NCT00061633's enrollment target sits among peer trials
169 6th of 36 higher than 31 of 36 other Burns trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Burns 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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