Omadacycline for Treatment Refractory Mycoplasma Genitalium Urethritis

Summary

Urethritis from Mycoplasma genitalium is difficult to treat and often does not respond to first line therapy. In this case series study, individuals who have failed first line therapy will receive omadacycline (provided by Paratek Pharmaceuticals) to determine the safety and feasibility of using this agent for this condition.

Timeline

Start

2026-10

Primary completion

2027-04

Completion

2027-04

Publications

• Background Waites KB, Crabb DM, Atkinson TP, Geisler WM, Xiao L. Omadacycline Is Highly Active In Vitro against Mycoplasma genitalium. Microbiol Spectr. 2022 Dec 21;10(6):e0365422. doi: 10.1128/spectrum.03654-22. Epub 2022 Oct 31.
• Background Patel NM. Case Report: First In-Human Report of Cure of Refractory Mycoplasma genitalium Infection With Omadacycline. Open Forum Infect Dis. 2026 Mar 30;13(Suppl 2):S1398-S1401. doi: 10.1093/ofid/ofag030. eCollection 2026 Apr.
• Background Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1.
• Background Hedstrom M, Carlsson M, Ekman A, Gillespie U, Mork C, Asberg KH. Development of the PHASE-Proxy scale for rating drug-related signs and symptoms in severe cognitive impairment. Aging Ment Health. 2018 Jan;22(1):53-60. doi: 10.1080/13607863.2016.1232364. Epub 2016 Sep 22.

Drugs

Indications