Clinical Research Directory

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 feeding * Allergy or severe intolerance to omadacycline or any of its components * Baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), as determined on screening visit liver function tests (LFTs). * Baseline total bilirubin \> 1.5 × ULN * Suspected or confirmed clinical evidence of end-stage liver disease (e.g., ascites, hepatic encephalopathy) * Patient reported condomless sexual activity occurring between completion of first-line Mgen treatment and subsequent positive NAAT test * Inability of the patient to reasonably expect to avoid condomless sex during the study's 35-day follow-up period between starting study omadacycline and date of follow up test * Based on investigator judgement, significant uncertainty about adherence to prior first-line treatments * Based on investigator judgement, significant uncertainty about the subject's interest in or ability to adhere to omadacycline