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NCT02015637 · ClinicalTrials.gov registry record · Phase 3

Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea

A Phase 3 study, sponsored by Melinta Therapeutics.

Terminated
Registry status
Phase 3
Development phase
460
Enrollment target

NCT02015637: Clinical Trial Phase 3 study, sponsored by Melinta Therapeutics.

NCT02015637 is a Phase 3 study that was terminated before completion, run by Melinta Therapeutics. The registered enrollment target is 460 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02015637, a Phase 3 study, was terminated before completion, sponsored by Melinta Therapeutics.

TERMINATED
Registry status
Phase 3
Development phase
460 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the effects of a single oral dose of delafloxacin versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated cervical, urethral, rectal, or pharyngeal gonorrhea.

Primary Outcome

Cure for the primary outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC.

Interventions

  • DRUG Ceftriaxone
  • DRUG Delafloxacin

Trial Details

FieldValue
Enrollment Target 460 participants
Start Date 2014-01-23
Est. Completion 2014-12-10
Phase Phase 3
Melinta Therapeutics

31 total trials

Why NCT02015637 stopped before completion

NCT02015637 is an interventional study that assigns participants to a tested intervention. The registered 460 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 (40% lower).

The record links to 0 conditions, and to 2 interventions - of which Ceftriaxone is the first listed.

NCT02015637 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02015637 about?

NCT02015637 is a clinical study titled "Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea". The purpose of this study is to evaluate the effects of a single oral dose of delafloxacin versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated cervical, urethral, rectal, or pharyngeal gonorrhea.

What is the current status of trial NCT02015637?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2014-01-23. Estimated completion is 2014-12-10.

What interventions are being tested in trial NCT02015637?

The interventions under investigation include: Ceftriaxone (DRUG), Delafloxacin (DRUG).

Who is sponsoring clinical trial NCT02015637?

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 NCT02015637's enrollment target sits among peer trials

460 823rd of 2000 higher than 1,174 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 NCT02015637, the US trial registry maintained by the National Library of Medicine. NCT02015637 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.