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NCT01283581 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections
A Phase 2 study, sponsored by Melinta Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 256
- Enrollment target
NCT01283581: Completed Phase 2 study, sponsored by Melinta Therapeutics.
NCT01283581 is a Phase 2 study that has completed, run by Melinta Therapeutics. The registered enrollment target is 256 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01283581, a Phase 2 study, has completed, sponsored by Melinta Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 256 participants
- Enrollment target
Study Summary
The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical trials
Primary Outcome
The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.
Interventions
- DRUG Vancomycin
- DRUG Linezolid
- DRUG Delafloxacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT01283581 record still lists
NCT01283581 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% higher).
The record links to 0 conditions, and to 3 interventions - of which Vancomycin is the first listed.
NCT01283581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01283581 about?
NCT01283581 is a clinical study titled "A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections". The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical trials
What is the current status of trial NCT01283581?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 256 participants. The study started on 2011-01. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01283581?
The interventions under investigation include: Vancomycin (DRUG), Linezolid (DRUG), Delafloxacin (DRUG).
Who is sponsoring clinical trial NCT01283581?
This trial is sponsored by Melinta Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01283581's enrollment target sits among peer trials
256 215th of 2000 higher than 1,783 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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