Phase
Condition
Urinary Incontinence
Gynecological Infections
Urinary Tract Infections
Treatment
Gepotidacin
Clinical Study ID
Ages > 12 Female
Study Summary
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
Connect with a study center
GSK Investigational Site
Birmingham, Alabama 35205-1628
United StatesSite Not Available
GSK Investigational Site
Los Angeles, California 900027
United StatesSite Not Available
GSK Investigational Site
Modesto, California 95350-5365
United StatesSite Not Available
GSK Investigational Site
North Hollywood, California 91606-3287
United StatesSite Not Available
GSK Investigational Site
Pasadena, California 91101-2453
United StatesSite Not Available
GSK Investigational Site
San Diego, California 92120-5259
United StatesSite Not Available
GSK Investigational Site
Valencia, California 91355
United StatesSite Not Available
GSK Investigational Site
Hialeah, Florida 33016
United StatesSite Not Available
GSK Investigational Site
Miami, Florida 33135
United StatesSite Not Available
GSK Investigational Site
Ormond Beach, Florida 32174-6302
United StatesSite Not Available
GSK Investigational Site
Palm Springs, Florida 33406-7671
United StatesSite Not Available
GSK Investigational Site
Plant City, Florida 33563-4202
United StatesSite Not Available
GSK Investigational Site
Sweetwater, Florida 33172-2741
United StatesSite Not Available
GSK Investigational Site
West Palm Beach, Florida 33409-3401
United StatesSite Not Available
GSK Investigational Site
Smyrna, Georgia 30082-5192
United StatesSite Not Available
GSK Investigational Site
East Brunswick, New Jersey 08816-1407
United StatesSite Not Available
GSK Investigational Site
W. New York, New Jersey 07093-2622
United StatesSite Not Available
GSK Investigational Site
New York, New York 10016-7313
United StatesSite Not Available
GSK Investigational Site
Raleigh, North Carolina 27612
United StatesSite Not Available
GSK Investigational Site
Cincinnati, Ohio 45215-1170
United StatesSite Not Available
GSK Investigational Site
Columbus, Ohio 43228
United StatesSite Not Available
GSK Investigational Site
Dayton, Ohio 45424
United StatesSite Not Available
GSK Investigational Site
Scottdale, Pennsylvania 15683
United StatesSite Not Available
GSK Investigational Site
Forney, Texas 75126-4174
United StatesSite Not Available
GSK Investigational Site
Houston, Texas 77087
United StatesSite Not Available
GSK Investigational Site
Kingwood, Texas 26537
United StatesSite Not Available
GSK Investigational Site
Mesquite, Texas 75149
United StatesSite Not Available
GSK Investigational Site
Missouri City, Texas 77459-4756
United StatesSite Not Available
GSK Investigational Site
Bountiful, Utah 84010-4943
United StatesSite Not Available
GSK Investigational Site
Morgantown, West Virginia 26501
United StatesSite Not Available
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