Montefiore Medical Center
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.
Treatment refractory Mycoplasma genitalium (Mgen) urethritis is an extremely difficult-to-manage clinical entity with inadequate therapeutic options. There are no guidelines for management of patients who fail first-line therapy, with case reports and case series providing limited data into second-line/salvage therapy. In vitro data suggests omadacycline may be active against Mgen and a recent case report provided details on the first refractory case of Mgen cured after omadacycline. In this study individuals with symptomatic Mgen urethritis who have failed first-line therapy (doxycycline foll…
Inclusion Criteria: * Age ≥18 years * Symptomatic urethritis (dysuria, urethral discomfort, pain, or discharge) from Mgen (exclusion of Chlamydia trachomatis, Neisseria gonorrhea, and Trichomonas vaginalis by NAAT) * Treatment-refractory infection, defined as persistent symptoms and Mgen NAAT positivity ≥21 days after completion of initial treatment. Initial treatment based on Centers for Disease Control and Prevention (CDC) guidelines: doxycycline (100 mg twice daily for seven days) followed by moxifloxacin (400 mg once daily for seven days) Exclusion Criteria: * Pregnancy or breast feedin…
Patients will receive 28 tablets of 150 milligrams (mg) of omadacycline, taken as 300 mg daily for 14 days.
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