A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants W… (NCT05630833) | Clinical Trial Compass
CompletedPhase 3
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
Japan380 participantsStarted 2023-01-11
Plain-language summary
The purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin in female participants with acute uncomplicated cystitis with qualifying bacterial uropathogen(s) at baseline that all are susceptible to nitrofurantoin in Japan, with that from global studies (Studies 204989 \[NCT04020341\] and 212390 \[NCT04187144\]).
Who can participate
Age range12 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The participant has a body weight \>=40 kilograms (kg).
* The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset less than (\<) 96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain.
* The participant has nitrite or pyuria (greater than \[\>\]15 white blood cell \[WBC\]/high-power field \[HPF\] or the presence of 3 plus (+) /large leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures.
* The participant is capable of giving signed informed consent/assent.
Exclusion Criteria:
* The participant resides in a nursing home or dependent care type facility.
* The participant has a body mass index \>=40.0 kilogram per meter square (kg/m\^2) or a body mass index \>=35.0 kg/m\^2 and is experiencing obesity-related health conditions such as uncontrolled high blood pressure or uncontrolled diabetes.
* The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications.
* The participant has any of the following:
* Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severe pain; Active peptic ulcer disease; Parkinson disease; Myasthenia gravis; a history of seizure disorder requiring medications for control (this does not include a history of childhood febrile seizures); Or
* Known acute porphyria.
* Any surgi…
What they're measuring
1
Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit