[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urethritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urethritis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100658815","phase-2-omadacycline-for-treatment-refractory-mycoplasma-genitalium-urethritis-100658815",false,"NCT07853742","Omadacycline for Treatment Refractory Mycoplasma Genitalium Urethritis","Inclusion Criteria:\n\n* Age ≥18 years\n* Symptomatic urethritis (dysuria, urethral discomfort, pain, or discharge) from Mgen (exclusion of Chlamydia trachomatis, Neisseria gonorrhea, and Trichomonas vaginalis by NAAT)\n* 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)\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n* Allergy or severe intolerance to omadacycline or any of its components\n* Baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), as determined on screening visit liver function tests (LFTs).\n* Baseline total bilirubin \\> 1.5 × ULN\n* Suspected or confirmed clinical evidence of end-stage liver disease (e.g., ascites, hepatic encephalopathy)\n* Patient reported condomless sexual activity occurring between completion of first-line Mgen treatment and subsequent positive NAAT test\n* 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\n* Based on investigator judgement, significant uncertainty about adherence to prior first-line treatments\n* Based on investigator judgement, significant uncertainty about the subject's interest in or ability to adhere to omadacycline","ALL","18 Years",{"count":18,"type":19},10,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","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.",[25,26],"Mycoplasma Genitalium Infection","Urethritis",[28],"Omadacycline","NOT_YET_RECRUITING","2026-09-25",{"date":32,"type":33},"2026-10-02","ACTUAL",{"date":35,"type":19},"2026-10",{"date":37,"type":19},"2027-04",{"name":39,"class":40},"Montefiore Medical Center","OTHER"]