A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)

Last updated: March 24, 2025
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Urinary Incontinence

Gynecological Infections

Urinary Tract Infections

Treatment

Gepotidacin

Clinical Study ID

NCT06597344
219575
  • Ages > 12
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants having >=12 years of age at the time of signing the informedconsent/assent and have a body weight >=40 kilograms (kg).

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

  • The participant has nitrite or pyuria (presence of 3 plus (+)/large leukocyteesterase) on a urine dipstick test from a pre-treatment clean-catch midstream urinesample.

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

  • The participant is female.

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 has a history of sensitivity to the study treatment, or componentsthereof, or a history of a drug or other allergy that, in the opinion of theinvestigator or medical monitor, contraindicates her participation.

  • The participant is immunocompromised or has altered immune defences 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;

  • A history of seizure disorder requiring medications for control (this does notinclude a history of childhood febrile seizures) Or

  • Any surgical or medical condition (active or chronic) that may interfere with drugabsorption, distribution, metabolism, or excretion of the study intervention.

  • 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 a serious underlying disease that could be imminently lifethreatening, or the participant is unlikely to survive for the duration of the studyperiod.

  • 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 Pseudomonasaeruginosa or Enterobacterales (other than Escherichia coli) as the contributingpathogen.

  • The participant has symptoms known or suspected to be caused by another diseaseprocess, such as overactive bladder, chronic incontinence, or chronic interstitialcystitis, that may interfere with the clinical efficacy assessments or precludecomplete resolution of uUTI 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 (for example [e.g.], polycystic renal disease), or neurogenic bladder, orthe participant has a history of anatomical or functional abnormalities of theurinary tract (e.g., chronic vesico-ureteral 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 >=101.4 degreeFahrenheit (>=38 Degrees Celsius [°C]), flank pain, chills, or any othermanifestations suggestive of upper UTI.

  • The participant has known anuria, oliguria, or significant impairment of renalfunction (creatinine clearance <30 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 the QTcinterval.

  • 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 oftorsade 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 or a strong P-gp inhibitor

  • The participant has a mean triplicate QTc >450 msec or a mean triplicate QTc >480msec for participants with bundle-branch block.

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

  • The participant has a known ALT value >2 times upper limit of normal (ULN).

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

  • The participant has a current or chronic history of liver disease or known hepaticor biliary abnormalities (with the exception of Gilbert's syndrome or asymptomaticgallstones), including symptomatic viral hepatitis or moderate-to-severe liverinsufficiency (Child Pugh class B or C).

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

  • The participant plans to use any of the prohibited medications or nondrug therapiesfrom the Baseline Visit through 7 days after the first dose of study intervention.

  • The participant has been previously enrolled in this study or has previously beentreated with gepotidacin.

  • The participant has participated in a clinical trial and has received aninvestigational product within 30 days or 5 half-lives, whichever is longer.

Study Design

Total Participants: 97
Treatment Group(s): 1
Primary Treatment: Gepotidacin
Phase: 3
Study Start date:
October 02, 2024
Estimated Completion Date:
March 10, 2025

Connect with a study center

  • GSK Investigational Site

    Birmingham, Alabama 35205-1628
    United States

    Site Not Available

  • GSK Investigational Site

    Los Angeles, California 900027
    United States

    Site Not Available

  • GSK Investigational Site

    Modesto, California 95350-5365
    United States

    Site Not Available

  • GSK Investigational Site

    North Hollywood, California 91606-3287
    United States

    Site Not Available

  • GSK Investigational Site

    Pasadena, California 91101-2453
    United States

    Site Not Available

  • GSK Investigational Site

    San Diego, California 92120-5259
    United States

    Site Not Available

  • GSK Investigational Site

    Valencia, California 91355
    United States

    Site Not Available

  • GSK Investigational Site

    Hialeah, Florida 33016
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33135
    United States

    Site Not Available

  • GSK Investigational Site

    Ormond Beach, Florida 32174-6302
    United States

    Site Not Available

  • GSK Investigational Site

    Palm Springs, Florida 33406-7671
    United States

    Site Not Available

  • GSK Investigational Site

    Plant City, Florida 33563-4202
    United States

    Site Not Available

  • GSK Investigational Site

    Sweetwater, Florida 33172-2741
    United States

    Site Not Available

  • GSK Investigational Site

    West Palm Beach, Florida 33409-3401
    United States

    Site Not Available

  • GSK Investigational Site

    Smyrna, Georgia 30082-5192
    United States

    Site Not Available

  • GSK Investigational Site

    East Brunswick, New Jersey 08816-1407
    United States

    Site Not Available

  • GSK Investigational Site

    W. New York, New Jersey 07093-2622
    United States

    Site Not Available

  • GSK Investigational Site

    New York, New York 10016-7313
    United States

    Site Not Available

  • GSK Investigational Site

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • GSK Investigational Site

    Cincinnati, Ohio 45215-1170
    United States

    Site Not Available

  • GSK Investigational Site

    Columbus, Ohio 43228
    United States

    Site Not Available

  • GSK Investigational Site

    Dayton, Ohio 45424
    United States

    Site Not Available

  • GSK Investigational Site

    Scottdale, Pennsylvania 15683
    United States

    Site Not Available

  • GSK Investigational Site

    Forney, Texas 75126-4174
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77087
    United States

    Site Not Available

  • GSK Investigational Site

    Kingwood, Texas 26537
    United States

    Site Not Available

  • GSK Investigational Site

    Mesquite, Texas 75149
    United States

    Site Not Available

  • GSK Investigational Site

    Missouri City, Texas 77459-4756
    United States

    Site Not Available

  • GSK Investigational Site

    Bountiful, Utah 84010-4943
    United States

    Site Not Available

  • GSK Investigational Site

    Morgantown, West Virginia 26501
    United States

    Site Not Available

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