A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)

Last updated: March 7, 2025
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Gynecological Infections

Urinary Tract Infections

Bladder Disorders

Treatment

Nitrofurantoin

Placebo

Gepotidacin

Clinical Study ID

NCT05630833
214144
  • Ages > 12
  • Female

Study Summary

The purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin in female participants with acute uncomplicated cystitis with qualifying bacterial uropathogen(s) at baseline that all are susceptible to nitrofurantoin in Japan, with that from global studies (Studies 204989 [NCT04020341] and 212390 [NCT04187144]).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The participant has a body weight >=40 kilograms (kg).

  • The participant has 2 or more of the following clinical signs and symptoms of acutecystitis with onset less than (<) 96 hours prior to study entry: dysuria, frequency,urgency, or lower abdominal pain.

  • The participant has nitrite or pyuria (greater than [>]15 white blood cell [WBC]/high-power field [HPF] or the presence of 3 plus (+) /large leukocyteesterase) from a pretreatment clean-catch midstream urine sample based on locallaboratory procedures.

  • The participant is capable of giving signed informed consent/assent.

Exclusion

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 abody mass index >=35.0 kg/m^2 and is experiencing obesity-related health conditionssuch as uncontrolled high blood pressure or uncontrolled diabetes.

  • The participant is immunocompromised or has altered immune defenses that maypredispose the participant to a higher risk of treatment failure and/orcomplications.

  • The participant has any of the following:

  • Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severepain; Active peptic ulcer disease; Parkinson disease; Myasthenia gravis; ahistory of seizure disorder requiring medications for control (this does notinclude a history of childhood febrile seizures); Or

  • Known acute porphyria.

  • Any surgical or medical condition (active or chronic) that may interfere withdrug absorption, distribution, metabolism, or excretion of the studyintervention.

  • The participant has a known glucose-6-phosphate dehydrogenase deficiency.

  • The participant, in the judgment of the investigator, would not be able or willingto comply with the protocol or complete study follow-up.

  • The participant has acute uncomplicated cystitis that is known or suspected to bedue to fungal, parasitic, or viral pathogens; or known or suspected to be due toPseudomonas aeruginosa or Enterobacterales (other than E. coli) as the contributingpathogen.

  • The participant has symptoms known or suspected to be caused by another diseaseprocess, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence,or chronic interstitial cystitis, that may interfere with the clinical efficacyassessments or preclude complete resolution of acute cystitis symptoms.

  • The participant has an anatomical or physiological anomaly that predisposes theparticipant to UTIs or may be a source of persistent bacterial colonization,including calculi, obstruction or stricture of the urinary tract, primary renaldisease (e.g., polycystic renal disease), or neurogenic bladder, or the participanthas a history of anatomical or functional abnormalities of the urinary tract (e.g.,chronic vesicoureteral reflux, detrusor insufficiency).

  • The participant has an indwelling catheter, nephrostomy, ureter stent, or otherforeign material in the urinary tract.

  • The participant who, in the opinion of the investigator, has an otherwisecomplicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs andsymptom onset >=96 hours before study entry, or a temperature >=38 Degrees Celsius [°C], flank pain, chills, or any other manifestations suggestive of upper UTI.

  • The participant has known anuria, oliguria, or significant impairment of renalfunction (creatinine clearance <60 milliliters per minute (mL/min) or clinicallysignificant elevated serum creatinine as determined by the investigator).

  • The participant presents with vaginal discharge at Baseline (e.g., suspectedsexually transmitted disease).

  • The participant has congenital long QT syndrome or known prolongation of thecorrected QT (QTc) interval.

  • The participant has uncompensated heart failure.

  • The participant has severe left ventricular hypertrophy.

  • The participant has a family history of QT prolongation or sudden death.

  • The participant has a recent history of vasovagal syncope or episodes of symptomaticbradycardia or brady arrhythmia within the last 12 months.

  • The participant is taking QT-prolonging drugs or drugs known to increase the risk oftorsades de pointes (TdP) per the www.crediblemeds.org. "Known Risk of TdP" categoryat the time of her Baseline Visit, which cannot be safely discontinued from theBaseline Visit to the TOC Visit; or the participant is taking a strong cytochromeP450 enzyme 3A4 (CYP3A4) inhibitor.

  • For any participant >=12 to <18 years of age, the participant has an abnormal ECGreading at Baseline.

  • The participant has a QTc >450 msec or a QTc >480 msec for participants with bundlebranch block.

  • The participant has a documented or recent history of uncorrected hypokalemia withinthe past 3 months.

  • The participant has a known alanine aminotransferase (ALT) value >2 times upperlimit of normal (ULN).

  • The participant has a known total bilirubin value >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35percent [%]).

  • The participant has cirrhosis or current unstable liver or biliary disease perinvestigator assessment defined by the presence of ascites, encephalopathy,coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistentjaundice.

  • The participant has a previous history of cholestatic jaundice/hepatic dysfunctionassociated with nitrofurantoin.

  • The participant has received treatment with other systemic antimicrobials orsystemic antifungals within 1 week before study entry.

Study Design

Total Participants: 380
Treatment Group(s): 3
Primary Treatment: Nitrofurantoin
Phase: 3
Study Start date:
January 11, 2023
Estimated Completion Date:
February 02, 2024

Connect with a study center

  • GSK Investigational Site

    Chiba, 270-0034
    Japan

    Site Not Available

  • GSK Investigational Site

    Fukuoka, 814-0013
    Japan

    Site Not Available

  • GSK Investigational Site

    Gunma, 370-0826
    Japan

    Site Not Available

  • GSK Investigational Site

    Hokkaido, 006-0816
    Japan

    Site Not Available

  • GSK Investigational Site

    Ibaraki, 300-0062
    Japan

    Site Not Available

  • GSK Investigational Site

    Kagoshima, 890-0073
    Japan

    Site Not Available

  • GSK Investigational Site

    Kanagawa, 232-0067
    Japan

    Site Not Available

  • GSK Investigational Site

    Kochi, 781-0085
    Japan

    Site Not Available

  • GSK Investigational Site

    Miyagi, 980-0803
    Japan

    Site Not Available

  • GSK Investigational Site

    Osaka, 564-0063
    Japan

    Site Not Available

  • GSK Investigational Site

    Saga, 840-0831
    Japan

    Site Not Available

  • GSK Investigational Site

    Saitama, 352-0001
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokyo, 130-0026
    Japan

    Site Not Available

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