This research study is being done to learn more about bladder infections also known as uncomplicated urinary tract infection (uUTI), and if a new medicine called gepotidacin can be used for this infectio
- Conditions
- Health Condition 1: N300- Acute cystitis
- Registration Number
- CTRI/2020/07/026741
- Lead Sponsor
- GlaxoSmithKlineResearchandDevelopmentLimited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Age
1.The participant is =12 years of age 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 enroll in the study, study sites must follow their institutional ethics committee and local country/national regulatory guidelines 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 =72 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain.
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 laboratory procedures.
Sex
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.
•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 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)/assent form and in this protocol.
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 high blood pressure or uncontrolled diabetes.
3.The participant has a history of sensitivity to the study interventions, 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.
4.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 <1000/µL], and participants receiving immunosuppressive therapy, including corticosteroid therapy [ >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.
5.The participant has any of the following:
•Medical condition that requires medication that may be impacted by inhibition of acetylcholinesterase, such as:
•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
•Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention (e.g., ileostomy or malabsorption syndrome)
6.The participant has a known glucose-6-phosphate dehydrogenase deficiency.
7.The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
8.The participant has a serious underlying disease that could be imminently life-threatening, or the participant is unlikely to survive for the duration of the study period.
Urinary Tract Infection/Renal/Urogenital Exclusions
9.The participant has acute 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 Enterobacteriaceae (other than E. coli) as the contributing pathogen.
10.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.
11.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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the combined clinical and microbiological efficacy of gepotidacin compared to nitrofurantoin, at the Test of Cure (TOC) Visit, in female participants with acute cystitis in the Microbiological Intent-to-Treat nitrofurantoin Susceptible (micro ITT NTF-S) PopulationTimepoint: Number of participants with therapeutic response at the Test-of-Cure (TOC) visit [ Time Frame: Up to Day 13 ]
- Secondary Outcome Measures
Name Time Method