Overview

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

Status:
Completed

Trial end date:
2017-02-22

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Cempra Inc
Melinta Therapeutics, Inc.

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Treatments:

Azithromycin
Ceftriaxone
Solithromycin