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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Gepotidacin will be administered.
GSK Investigational Site
Modesto, California, United States
Percentage of Participants Achieving Clinical Symptom Improvement at 24 Hours (±4 Hours)
Clinical Symptom improvement is defined as a decrease from Baseline in CSS (Clinical Symptom Score) total score of at least 1 point at 24 hours (±4 hours), without the need for other systemic antimicrobials. CSS Score ranges from 0 to 12. Higher scores indicate a higher presence and severity of UTI symptoms.
Time frame: At 24 hours (h) (±4 h)
Percentage of Participants Achieving Clinical Symptom Improvement
Clinical Symptom improvement is defined as a decrease from Baseline in CSS total score of at least 1 point at each timepoint(i.e.,48 hours (±4 hours), 72 hours (±4 hours), and 96 hours (±4 hours)), without the need for other systemic antimicrobials. CSS Score ranges from 0 to 12. Higher scores indicate a higher presence and severity of UTI symptoms.
Time frame: At 48 hours (h) (±4 h), 72 hours (±4 h), 96 hours (±4 h)
Percentage of Participants Achieving Clinical Symptom Resolution
Clinical Symptom resolution is defined as a decrease from Baseline to a CSS total score of 0 at each timepoint(i.e., 24 hours (±4 hours), 48 hours (±4 hours), 72 hours (±4 hours), and 96 hours (±4 hours)) without the need for other systemic antimicrobials. CSS Score ranges from 0 to 12. Higher scores indicate a higher presence and severity of UTI symptoms.
Time frame: At 24 hours (±4 h), 48 hours (±4 h), 72 hours (±4 h), 96 hours (±4 h)
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AE of Special Interest (AESIs)
Adverse Event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death,is life-threatening,required hospitalization or prolongation of existing hospitalization,resulted in disability/incapacity,is congenital anomaly/birth defect, other situations which involved medical or scientific judgment or was associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs displayed are TEAEs defined as any AE with an onset date/time on or after treatment start date/time. AESIs include cardiovascular(CV) AEs, gastrointestinal(GI) AEs, clostridioides difficile-associated diarrhea (C. difficile AEs), Acetylcholinesterase Inhibition(AchE-I). AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA). The AE data presented below is of frequency threshold-0%.
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GSK Investigational Site
Pasadena, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Valencia, California, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Ormond Beach, Florida, United States
GSK Investigational Site
Palm Springs, Florida, United States
GSK Investigational Site
Palm Springs, Florida, United States
GSK Investigational Site
Plant City, Florida, United States
GSK Investigational Site
Sweetwater, Florida, United States
...and 12 more locations
Time frame: Up to 159 days