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