Phase
Condition
Gynecological Infections
Urinary Tract Infections
Bladder Disorders
Treatment
Nitrofurantoin
Placebo
Gepotidacin
Clinical Study ID
Ages > 12 Female
Study Summary
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
Connect with a study center
GSK Investigational Site
Chiba, 270-0034
JapanSite Not Available
GSK Investigational Site
Fukuoka, 814-0013
JapanSite Not Available
GSK Investigational Site
Gunma, 370-0826
JapanSite Not Available
GSK Investigational Site
Hokkaido, 006-0816
JapanSite Not Available
GSK Investigational Site
Ibaraki, 300-0062
JapanSite Not Available
GSK Investigational Site
Kagoshima, 890-0073
JapanSite Not Available
GSK Investigational Site
Kanagawa, 232-0067
JapanSite Not Available
GSK Investigational Site
Kochi, 781-0085
JapanSite Not Available
GSK Investigational Site
Miyagi, 980-0803
JapanSite Not Available
GSK Investigational Site
Osaka, 564-0063
JapanSite Not Available
GSK Investigational Site
Saga, 840-0831
JapanSite Not Available
GSK Investigational Site
Saitama, 352-0001
JapanSite Not Available
GSK Investigational Site
Tokyo, 130-0026
JapanSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.