A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)
NCT ID: NCT04020341
Last Updated: 2023-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1531 participants
INTERVENTIONAL
2019-10-17
2022-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Gepotidacin
Participants will be administered oral doses of 1500 milligrams (mg) gepotidacin plus nitrofurantoin matching placebo twice daily (BID); approximately every 12 hours for 5 days
Gepotidacin
Gepotidacin will be available as tablets containing 750 mg gepotidacin. Each dose should be taken with water after consumption of food.
Placebo matching nitrofurantoin
Placebo matching nitrofurantoin will be available as over-encapsulated unit-dose capsules. Each dose should be taken with water after consumption of food.
Nitrofurantoin
Participants will be administered oral doses of 100 mg nitrofurantoin plus gepotidacin matching placebo BID; approximately every 12 hours for 5 days.
Nitrofurantoin
Nitrofurantoin will be available as over-encapsulated capsules containing 25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin. Each dose should be taken with water after consumption of food.
Placebo matching gepotidacin
Placebo matching gepotidacin will be available as unit-dose gepotidacin placebo-to-match tablet. Each dose should be taken with water after consumption of food.
Interventions
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Gepotidacin
Gepotidacin will be available as tablets containing 750 mg gepotidacin. Each dose should be taken with water after consumption of food.
Placebo matching nitrofurantoin
Placebo matching nitrofurantoin will be available as over-encapsulated unit-dose capsules. Each dose should be taken with water after consumption of food.
Nitrofurantoin
Nitrofurantoin will be available as over-encapsulated capsules containing 25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin. Each dose should be taken with water after consumption of food.
Placebo matching gepotidacin
Placebo matching gepotidacin will be available as unit-dose gepotidacin placebo-to-match tablet. Each dose should be taken with water after consumption of food.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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:
1. Poorly controlled asthma or chronic obstructive pulmonary disease; acute severe pain; active peptic ulcer disease; Parkinson disease; myasthenia gravis; Or
2. Known acute porphyria.
3. 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.
12 Years
FEMALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Beverly Hills, California, United States
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Chula Vista, California, United States
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La Mesa, California, United States
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Lomita, California, United States
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Long Beach, California, United States
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Northridge, California, United States
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Northridge, California, United States
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Palm Springs, California, United States
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San Diego, California, United States
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DeLand, Florida, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami Springs, Florida, United States
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Orlando, Florida, United States
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Pompano Beach, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Fayetteville, Georgia, United States
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Wichita, Kansas, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Watertown, Massachusetts, United States
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Dearborn Heights, Michigan, United States
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Norfolk, Nebraska, United States
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East Brunswick, New Jersey, United States
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Albuquerque, New Mexico, United States
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Endwell, New York, United States
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Fayetteville, North Carolina, United States
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Scottdale, Pennsylvania, United States
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Smithfield, Pennsylvania, United States
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Clarksville, Tennessee, United States
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Memphis, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Corpus Christi, Texas, United States
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Forney, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Blagoevgrad, , Bulgaria
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Dupnitsa, , Bulgaria
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Pernik, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sliven, , Bulgaria
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Smolyan, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Yambol, , Bulgaria
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Bory, , Czechia
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Kromeríž, , Czechia
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Prague, , Czechia
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Giessen, Hesse, Germany
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Essen, North Rhine-Westphalia, Germany
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Mülheim, North Rhine-Westphalia, Germany
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Berlin, , Germany
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Hamburg, , Germany
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Heraklion, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Ballószög, , Hungary
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Csongrád, , Hungary
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Nyíregyháza, , Hungary
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Orosháza-Szentetornya, , Hungary
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Ahmedabad, , India
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Surat, , India
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Varanasi, , India
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Ciudad de Mexico, Campeche, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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San Juan del Río, Querétaro, Mexico
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Jalisco, , Mexico
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Iași, , Romania
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Oradea, , Romania
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Timișoara, , Romania
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Bratislava, , Slovakia
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Košice, , Slovakia
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Nitra, , Slovakia
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Pruské, , Slovakia
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Šaľa, , Slovakia
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Trenčín, , Slovakia
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Trenčín, , Slovakia
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Alicante, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Vic, , Spain
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Crownhill, Plymouth, , United Kingdom
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Liskeard, , United Kingdom
GSK Investigational Site
Peterborough, , United Kingdom
Countries
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References
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Scangarella-Oman NE, Butler DL, Breton J, Brown D, Kasapidis C, Sheets AJ. Efficacy and in vitro activity of gepotidacin against bacterial uropathogens, including subsets with molecularly characterized resistance mechanisms and genotypes/epidemiological clones, in females with uncomplicated urinary tract infections: results from two global, pivotal, phase 3 trials (EAGLE-2 and EAGLE-3). Antimicrob Agents Chemother. 2025 Oct;69(10):e0163924. doi: 10.1128/aac.01639-24. Epub 2025 Sep 9.
Scangarella-Oman NE, Butler DL, Breton J, Brown D, Kasapidis C, Millns H, Huang C, Perry CR, Sheets AJ, Dennison J, Janmohamed S. Efficacy and in vitro activity of gepotidacin against bacterial uropathogens, including drug-resistant phenotypes, in females with uncomplicated urinary tract infections: results from two global, pivotal, phase 3 trials (EAGLE-2 and EAGLE-3). Antimicrob Agents Chemother. 2025 Oct;69(10):e0164024. doi: 10.1128/aac.01640-24. Epub 2025 Sep 9.
Hackel MA, Karlowsky JA, Sahm DF, West JM, Scangarella-Oman NE. In vitro activity of gepotidacin against urinary tract infection isolates of Enterobacterales, Enterococcus faecalis, and Staphylococcus saprophyticus. Antimicrob Agents Chemother. 2025 Jun 4;69(6):e0029625. doi: 10.1128/aac.00296-25. Epub 2025 May 15.
Wagenlehner F, Perry CR, Hooton TM, Scangarella-Oman NE, Millns H, Powell M, Jarvis E, Dennison J, Sheets A, Butler D, Breton J, Janmohamed S. Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials. Lancet. 2024 Feb 24;403(10428):741-755. doi: 10.1016/S0140-6736(23)02196-7. Epub 2024 Feb 8.
Perry C, Hossain M, Powell M, Raychaudhuri A, Scangarella-Oman N, Tiffany C, Xu S, Dumont E, Janmohamed S. Design of Two Phase III, Randomized, Multicenter Studies Comparing Gepotidacin with Nitrofurantoin for the Treatment of Uncomplicated Urinary Tract Infection in Female Participants. Infect Dis Ther. 2022 Dec;11(6):2297-2310. doi: 10.1007/s40121-022-00706-9. Epub 2022 Oct 21.
Fishman C, Caverly Rae JM, Posobiec LM, Laffan SB, Lerman SA, Pearson N, Janmohamed S, Dumont E, Nunn-Floyd D, Stanislaus DJ. Novel Bacterial Topoisomerase Inhibitor Gepotidacin Demonstrates Absence of Fluoroquinolone-Like Arthropathy in Juvenile Rats. Antimicrob Agents Chemother. 2022 Nov 15;66(11):e0048322. doi: 10.1128/aac.00483-22. Epub 2022 Oct 18.
Scangarella-Oman NE, Hossain M, Hoover JL, Perry CR, Tiffany C, Barth A, Dumont EF. Dose Selection for Phase III Clinical Evaluation of Gepotidacin (GSK2140944) in the Treatment of Uncomplicated Urinary Tract Infections. Antimicrob Agents Chemother. 2022 Mar 15;66(3):e0149221. doi: 10.1128/AAC.01492-21. Epub 2022 Jan 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-001801-98
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
204989
Identifier Type: -
Identifier Source: org_study_id
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