Clinical Trial: Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Comparative Evaluation of the Single-dose Efficacy of Oral Delafloxacin Versus the Single-dose Efficacy of an Intramuscular Injection of Ceftriaxone in Subjects With Uncomplicated Urogenital

Brief 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.

Detailed Summary:
Sponsor: Melinta Therapeutics, Inc.

Current Primary Outcome: Microbiological outcome of urogenital gonorrhea [ Time Frame: Day 7 (± 3 days) ]

All subjects will return for the Test-of-Cure Visit. However, culture and NAAT swabs will not be collected from anatomical sites with negative cultures and NAAT results, respectively, for N. gonorrhoeae from the Entry Visit. If results are not known, a swab will be collected at each anatomical site tested at the Entry Visit.


Original Primary Outcome: Microbiological outcome of urogenital gonorrhea [ Time Frame: Day 7 (± 3 days) ]

At the Test-of-Cure Visit, the subject will undergo a targeted physical examination; and provide a blood and microbiological specimen for clinical laboratory testing. Subjects will be assessed for microbiological and clinical cure.


Current Secondary Outcome:

  • Microbiological response at all anatomical sites [ Time Frame: Day 7 (± 3 days) ]
  • Resolution of signs and symptoms [ Time Frame: Day 7 (± 3 days) ]


Original Secondary Outcome: Same as current

Information By: Melinta Therapeutics, Inc.

Dates:
Date Received: December 13, 2013
Date Started: January 2014
Date Completion:
Last Updated: April 6, 2016
Last Verified: April 2016