Clinical Trial: Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open-Label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of Oral Solithromycin Compared to Single-Dose Intramuscular Ceftriaxone Plus Single-Dose Oral Azithro

Brief Summary: This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin resulted in 100% microbiological eradication in male and female patients with uncomplicated urogenital gonorrhea.

Detailed Summary:
Sponsor: Cempra Inc

Current Primary Outcome: To assess the eradication rate of Neisseria gonorrhoeae by culture following a single dose of oral solithromycin compared to single-dose intramuscular ceftriaxone plus oral azithromycin in the Microbiological Intent to Treat population. [ Time Frame: 7 days after treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To assess the safety and tolerability of a single oral dose of solithromycin compared to single-dose IM ceftriaxone plus single-dose oral azithromycin in patients with gonorrhea [ Time Frame: 7 days ]
    Adverse event frequency and severity will be compared between patients who received solithromycin and those who received ceftriaxone plus azithromycin
  • To compare bacterial eradication rates of N. gonorrhoeae from rectal or pharyngeal cultures following a single dose of oral solithromycin compared to single-dose IM ceftriaxone plus oral azithromycin. [ Time Frame: 7 days ]
  • To assess clearance or persistence of N. gonorrhoeae and Chlamydia trachomatis nucleic acid from male and female genital, pharyngeal and rectal specimens. [ Time Frame: 21 days after treatment ]


Original Secondary Outcome: Same as current

Information By: Cempra Inc

Dates:
Date Received: August 1, 2014
Date Started: August 2014
Date Completion: April 2017
Last Updated: September 20, 2016
Last Verified: September 2016