A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and … (NCT06597344) | Clinical Trial Compass
CompletedPhase 3
A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)
United States97 participantsStarted 2024-10-02
Plain-language summary
The study will be conducted to evaluate the clinical symptom improvement and safety of oral gepotidacin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
Who can participate
Age range12 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants having \>=12 years of age at the time of signing the informed consent/assent and have a body weight \>=40 kilograms (kg).
* 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.
* The participant has nitrite or pyuria (presence of 3 plus (+)/large leukocyte esterase) on a urine dipstick test from a pre-treatment clean-catch midstream urine sample.
* The participant is capable of giving signed informed consent/assent.
* The participant is female.
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 has a history of sensitivity to the study treatment, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates her participation.
* The participant is immunocompromised or has altered immune defences 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 p…
What they're measuring
1
Percentage of Participants Achieving Clinical Symptom Improvement at 24 Hours (±4 Hours)