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NCT01811732 · ClinicalTrials.gov registry record · Phase 3

Delafloxacin Versus 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
660
Enrollment target

NCT01811732: Completed Phase 3 study, sponsored by Melinta Therapeutics.

NCT01811732 is a Phase 3 study that has completed, run by Melinta Therapeutics. The registered enrollment target is 660 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01811732, a Phase 3 study, has completed, sponsored by Melinta Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
660 participants
Enrollment target

Study Summary

This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).

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 Placebo
  • DRUG Vancomycin
  • DRUG Aztreonam
  • DRUG Delafloxacin

Trial Details

FieldValue
Enrollment Target 660 participants
Start Date 2013-04
Est. Completion 2014-07
Phase Phase 3
Melinta Therapeutics

31 total trials

What the finished NCT01811732 record still lists

NCT01811732 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01811732 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01811732 about?

NCT01811732 is a clinical study titled "Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections". This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).

What is the current status of trial NCT01811732?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2013-04. Estimated completion is 2014-07.

What interventions are being tested in trial NCT01811732?

The interventions under investigation include: Placebo (DRUG), Vancomycin (DRUG), Aztreonam (DRUG), Delafloxacin (DRUG).

Who is sponsoring clinical trial NCT01811732?

This trial is sponsored by Melinta Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01811732's enrollment target sits among peer trials

660 556th of 2000 higher than 1,440 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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Source: ClinicalTrials.gov NCT01811732, the US trial registry maintained by the National Library of Medicine. NCT01811732 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.