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

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.

Timeline

Start

2014-08

Primary completion

2017-02-22

Completion

2017-02-22

Publications

• Chen MY, McNulty A, Avery A, Whiley D, Tabrizi SN, Hardy D, Das AF, Nenninger A, Fairley CK, Hocking JS, Bradshaw CS, Donovan B, Howden BP, Oldach D; Solitaire-U Team. Solithromycin versus ceftriaxone plus azithromycin for the treatment of uncomplicated genital gonorrhoea (SOLITAIRE-U): a randomised phase 3 non-inferiority trial. Lancet Infect Dis. 2019 Aug;19(8):833-842. doi: 10.1016/S1473-3099(19)30116-1. Epub 2019 Jun 10.

Drugs

Indications