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NCT01984684 · ClinicalTrials.gov registry record · Phase 3
Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
A Phase 3 study, sponsored by Melinta Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 850
- Enrollment target
NCT01984684: Completed Phase 3 study, sponsored by Melinta Therapeutics.
NCT01984684 is a Phase 3 study that has completed, run by Melinta Therapeutics. The registered enrollment target is 850 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01984684, a Phase 3 study, has completed, sponsored by Melinta Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 850 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.
Primary Outcome
A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had \<20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or
Interventions
- DRUG vancomycin
- DRUG delafloxacin
- DRUG aztreonam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 850 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT01984684 record still lists
NCT01984684 is an interventional study that assigns participants to a tested intervention. The registered 850 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 3 interventions - of which vancomycin is the first listed.
NCT01984684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01984684 about?
NCT01984684 is a clinical study titled "Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections". The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.
What is the current status of trial NCT01984684?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 850 participants. The study started on 2014-05. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01984684?
The interventions under investigation include: vancomycin (DRUG), delafloxacin (DRUG), aztreonam (DRUG).
Who is sponsoring clinical trial NCT01984684?
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 NCT01984684's enrollment target sits among peer trials
850 387th of 2000 higher than 1,612 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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