Omadacycline for Treatment Refractory Mycoplasma Genitalium Urethritis

Percentage of Participants with Microbiological Cure of Mycoplasma genitalium

Microbiological cure is defined as having a negative nucleic acid amplification test (NAAT) for Mycoplasma genitalium at the Day 35 test of cure visit. The NAAT is performed on a self-collected urine specimen or a urogenital swab. Participants with a positive NAAT result are classified as not cured (continue to have an active infection). Participants who do not attend the Day 35 (+/- 7 days) visit or from whom no evaluable specimen is obtained are classified as not cured. The denominator is all enrolled participants who received at least one dose of omadacycline. If any participants included in the study are unable to complete the full 14 days of the medication for any reason they will be evaluated based on their outcome from their Day 35 NAAT.

Safety and Tolerability of omadacycline

Safety and tolerability of omadacycline will be assessed in tandem using the 20-item PHArmacotherapeutical Symptom Evaluation (PHASE-20) rating scale. The scale consists of 19 specific potential drug-related symptoms plus 1 open-ended category and evaluates whether symptoms experienced during the follow-up period may be related to the medication. For each item, participants will be asked to "tick the box" that best describes symptoms they experienced over the last 2 weeks and circle the appropriate term(s) when a multi-symptom item is presented if all symptoms don't apply. Each of the 20 items is rated on a 4-point ordinal scale: 0 (No problem), 1 (Minor problem), 2 (Moderate problem), and 3 (Severe problem), yielding an overall possible score of 0-60 with higher scores being indicative of a greater burden of possible medication-related symptoms. The scale is administered by telephone at Day 14 and in person at Day 35. Scores are reported separately at each time point.

Number of Participants with One or More Treatment-Emergent Adverse Events

A treatment-emergent adverse event (TEAE) is defined as any adverse event with onset on or after the first dose of omadacycline. Events are identified by the investigator team assessment during the Day 14 (+/- 5 days) telephone contact and the Day 35 (+/- 7 days) clinic visit, and by participant-initiated reporting at any time during the study period. Each event is characterized by severity and by investigator-assessed relationship to omadacycline. Participants reporting more than one event are counted once.