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

Completed · Phase 3

Conditions studied: Uncomplicated Urogenital Gonorrhea

In brief

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.

Key facts

Study ID

NCT02210325

Run by

Melinta Therapeutics, Inc.

People needed

264

Starts

2014-08-01

Expected to finish

2017-02-22

Last updated by the study team

2017-09-11

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 1 of the following:
• Untreated male with urethral gonorrhea as determined by a screening laboratory test (either NAAT or culture) for N. gonorrhoeae within 2 weeks prior to study drug administration.
• Untreated female with cervical gonorrhea as determined by a screening laboratory test (either NAAT or culture) for N. gonorrhoeae within 2 weeks prior to study drug administration.
• Urethral (male) or cervical (female) Gram stain demonstrating Gram-negative intracellular diplococci and leukocytes.
• The patient must be willing to abstain from anal, oral, and vaginal sexual intercourse or use condoms for all of these until study completion.
• Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.

You may not qualify if…

• Confirmed or suspected complicated or systemic gonococcal infections such as pelvic inflammatory disease, epididymitis, arthritis, endocarditis, or disseminated gonococcal infection.
• Individuals who have already received antibiotic treatment for their gonorrhea.
• Use of systemic or intravaginal antibiotics within 7 days prior to study drug administration.
• Women who are pregnant or nursing.
• Men with suspected or confirmed rectal gonorrhea and symptoms of proctitis.
• History of significant intolerance or allergy to macrolide or cephalosporin antibiotics.

Where it is running

• Study site — Baltimore, Maryland, United States
• Study site — Cleveland, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Sydney, New South Wales, Australia
• Study site — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.