Status:
COMPLETED
A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Urinary Tract Infections
Eligibility:
FEMALE
12+ years
Phase:
PHASE3
Brief Summary
The study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of u...
Eligibility Criteria
Inclusion
- Participants having \>=12 years of age at the time of signing the informed consent/assent and have a body weight \>=40 kilograms (kg).
- Participants having 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.
- Participants having nitrite or pyuria (greater than \[\>\]15 white blood cells \[WBC\]/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 female.
- Participant is capable of giving signed informed consent/assent.
Exclusion
- Participant resides in a nursing home or dependent care type-facility.
- Participant has a body mass index \>=40.0 kilogram per square meter (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.
- Participant has a history of sensitivity to the study treatments, 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.
- Participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications.
- 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; 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.
- Participant has a known glucose-6-phosphate dehydrogenase deficiency.
- 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.
- 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 Enterobacterales (other than Escherichia coli) as the contributing pathogen.
- 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.
- 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 (for example \[e.g.\], polycystic renal disease), or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract (e.g., chronic vesico-ureteral reflux, detrusor insufficiency).
- Participant has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract.
- Participant who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs and symptom onset \>=96 hours before study entry, or a temperature \>=101.4 Degrees Fahrenheit (F) (\>=38 Degrees Celsius \[C\]), flank pain, chills, or any other manifestations suggestive of upper UTI.
- Participant has known anuria, oliguria, or significant impairment of renal function (creatinine clearance \<60 milliliter per minute \[mL/min\] or clinically significant elevated serum creatinine as determined by the investigator).
- Participant presents with vaginal discharge at Baseline (e.g., suspected sexually transmitted disease).
- Participant has congenital long QT syndrome or known prolongation of the corrected QT (QTc) interval.
- Participant has uncompensated heart failure.
- Participant has severe left ventricular hypertrophy.
- Participant has a family history of QT prolongation or sudden death.
- Participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady-arrhythmia within the last 12 months.
- Participant is taking QT-prolonging drugs or drugs known to increase the risk of torsades de pointes (TdP) per the www.crediblemeds.org. "Known Risk of TdP" category at the time of her Baseline Visit, which cannot be safely discontinued from the Baseline Visit to the TOC Visit; or the participant is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor.
- For any participant \>=12 to \<18 years of age, the participant has an abnormal electrocardiogram (ECG) reading.
- Participant has a QTc \>450 millisecond (msec) or a QTc \>480 msec for participants with bundle-branch block.
- Participant has a documented or recent history of uncorrected hypokalemia within the past 3 months.
- Participant has a known alanine aminotransferase (ALT) value \>2 times upper limit of normal (ULN).
- Participant has a known bilirubin value \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent \[%\]).
- Participant has a current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), including symptomatic viral hepatitis or moderate-to-severe liver insufficiency (Child Pugh class B or C).
- Participant has a previous history of cholestatic jaundice or hepatic dysfunction associated with nitrofurantoin.
- Participant has received treatment with other systemic antimicrobials or systemic antifungals within 1 week before study entry.
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
1531 Patients enrolled
Trial Details
Trial ID
NCT04020341
Start Date
October 17 2019
End Date
November 30 2022
Last Update
June 22 2023
Active Locations (103)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35205
2
GSK Investigational Site
Phoenix, Arizona, United States, 85051
3
GSK Investigational Site
Tucson, Arizona, United States, 85712
4
GSK Investigational Site
Beverly Hills, California, United States, 90211-2921