uncomplicated urinary tract infection (acute cystitis)
Conditions
Interventions
Participants will receive oral study treatment (gepotidacin [2 tablets] + nitrofurantoin matching placebo [1 capsule] or nitrofurantoin [1 capsule] + gepotidacin matching placebo [2 tablets]) BID (app
Sponsors
Okawa Yasutoshi
Eligibility
Sex/Gender
Female
Inclusion criteria
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 15 WBC/HPF or the presence of 3+/large leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures. Sex and Contraceptive/Barrier Requirements 4. The participant is female Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. -A female participant is eligible to participate if she is a woman of childbearing potential (WOCBP) who is not pregnant as confirmed by a high sensitivity urine pregnancy test at Baseline (Day 1) regardless of current or prior contraception use or abstinence, is not breastfeeding, or is not a WOCBP. Note: Pregnancy testing requirements, contraceptive guidance, and WOCBP definitions are provided in Section 10.4 and requirements for pregnancy testing during and after study treatment are located in Section 8.2.5. -Additional requirements for pregnancy testing during and after study treatment are located in in section 8.2.5. -The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Informed Consent 5. The participant is capable of giving signed informed consent/assent as described in Section 10.1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) /assent form and in this protocol.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions 1. The participant resides in a nursing home or dependent care type facility. 2. The participant has a body mass index >-40.0 kg/m2 or a body mass index >-35.0 kg/m2 and is experiencing obesity-related health conditions such as uncontrolled high blood pressure or uncontrolled diabetes. 3. The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications (e.g., uncontrolled diabetes, renal transplant recipients, participants with clinically significant persistent granulocytopenia [absolute neutrophil count 40 mg/day prednisolone or equivalent for >1 week, .20 mg/day prednisolone or equivalent for >2 weeks, or prednisolone or equivalent .10 mg/day for >6 weeks]). Participants with a known CD4 count of <200 cells/mm3 should not be enrolled. 4. The participant has any of the following: -Medical condition that requires medication that may be impacted by inhibition of acetylcholinesterase, such as: Clinical Study Protocol template V16 dated 24-Jun-2021 -Poorly controlled asthma or chronic obstructive pulmonary disease at Baseline and, in the opinion of the investigator, not stable on current therapy -Acute severe pain, uncontrolled with conventional medical management -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 surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study treatment (e.g., ileostomy or malabsorption syndrome) 5. The participant has a known glucose-6-phosphate dehydrogenase deficiency. 6. The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up. 7. The participant has a serious underlying disease that could be imminently lifethreatening, or the participant is unlikely to survive for the duration of the study period. 8. The participant has acute uncomplicated cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or Enterobacterales (other than E. coli) as the contributing pathogen. 9. The participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis, that may interfere with the clinical efficacy assessments or preclude complete resolution of acute cystitis symptoms. 10. The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract (e.g., chronic vesicoureteral reflux, detrusor insufficiency). 11. The participant has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract. 12. The participant wh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic response (combined perparticipant microbiological and clinical response) at the TOC Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactYasutoshi Okawa
GlaxoSmithKline K.K.
Outcome results
None listed