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

Uncomplicated Urogenital Gonorrhea Clinical Trial

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 Azithromycin in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea With or Without Concomitant Chlamydia

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Gonorrhea
• Uncomplicated Urogenital Gonorrhea

• NCT number: NCT02210325
• Study type: Interventional
• Source: Cempra Inc
• Status: Completed
• Phase: Phase 3
• Start date: August 2014
• Completion date: February 22, 2017