A study to investigate the efficacy and safety with gepotidacin in Japanese female participants with uncomplicated urinary tract infection (acute cystitis); Efficacy of Antibacterial Gepotidacin Evaluated in Japan (EAGLE-J)

INTERVENTION: Participants will receive oral study treatment (gepotidacin [2 tablets] + nitrofurantoin matching placebo [1 capsule] or nitrofurantoin [1 capsule] + gepotidacin matching placebo [2 tablets]) BID (approximately every 12 hours) for 5 days. CONDITION: uncomplicated urinary tract infection (acute cystitis) PRIMARY OUTCOME: Therapeutic response (combined perparticipant microbiological and clinical response) at the TOC Visit SECONDARY OUTCOME: Therapeutic response at the TOC Visit; Clinical outcome and response at the TOC Visit; Microbiological outcome and response at the TOC Visit; Therapeutic response at the TOC Visit; Clinical outcome and response at the TOC Visit; Microbiological outcome and response at the TOC Visit; Investigator assessment of clinical response at the TOC Visit; Occurrence of treatment‐emergent adverse events (AEs), serious AEs (SAEs) and adverse events of special interest (AESIs); Change from baseline in clinical laboratory tests; Change from baseline in electrocardiograms (ECGs); Gepotidacin plasma and urine concentrations; Change from baseline in vital sign measurements INCLUSION CRITERIA: Otherwise healthy Japanese participants are eligible to be included in the study only if all of the following criteria apply: Age 1. The participant must be >=12 years of age inclusive, at the time of signing the informed consent/assent and has a body weight >=40 kg. Note: Although participants as young as 12 years may enrol in the study, study sites must follow their institutional ethics committee and enrollment will be contingent upon such approvals regarding the allowed lower age limit for clinical study participants. Type of Participant and Disease Characteristics 2. The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset <96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain (see Section 10.10). 3. The participant has nitrite or pyuria (>15 WBC/HPF or the presence of 3+/large leukocyte esterase) from a pretreatment clean‐catch midstream urine sample based on local la