A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)

A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)

Sponsors

Lead Sponsor: GlaxoSmithKline

Source GlaxoSmithKline
Brief Summary

This study will be conducted to evaluate the therapeutic response of oral gepotidacin compared to oral nitrofurantoin for uncomplicated UTI in adolescent and adult female subjects. In this study, subjects will be randomly assigned in a 1:1 ratio to receive either oral gepotidacin or oral nitrofurantoin. The study will enroll approximately 2000 subjects with uncomplicated UTI. The duration of the study will be approximately 28 days.

Overall Status Recruiting
Start Date October 17, 2019
Completion Date December 22, 2022
Primary Completion Date December 22, 2022
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of subjects with therapeutic response at Test-of-Cure (TOC) visit Up to Day 13
Secondary Outcome
Measure Time Frame
Number of subjects with clinical response at the TOC visit Up to Day 13
Number of subjects with indicated clinical outcome at the TOC visit Up to Day 13
Number of subjects with clinical response at the follow-up visits Up to Day 31
Number of subjects with indicated clinical outcome at the follow-up visits Up to Day 31
Number of subjects with microbiological response at the TOC visit Up to Day 13
Number of subjects with indicated microbiological outcome at the TOC visit Up to Day 13
Number of subjects with microbiological response at the follow-up visits Up to Day 31
Number of subjects with indicated microbiological outcome at the follow-up visits Up to Day 31
Number of subjects with therapeutic response at follow-up visits Up to Day 31
Peak concentration of gepotidacin in plasma Day 1
Trough concentration of gepotidacin in plasma Up to Day 3
Peak concentration of gepotidacin in urine Day 1
Trough concentration of gepotidacin in urine Up to Day 3
Number of subjects with Treatment-emergent adverse events and serious adverse events (SAEs) Up to Day 31
Change from Baseline in neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count Baseline and up to Day 13
Change from Baseline in hemoglobin level Baseline and up to Day 13
Change from Baseline in hematocrit level Baseline and up to Day 13
Change from Baseline in red blood cell (RBC) count Baseline and up to Day 13
Change from Baseline in mean corpuscular hemoglobin (MCH) Baseline and up to Day 13
Change from Baseline in mean corpuscular volume (MCV) Baseline and up to Day 13
Change from Baseline in blood urea nitrogen, glucose non-fasting, calcium, chloride, sodium and potassium levels Baseline and up to Day 13
Change from Baseline in total bilirubin, direct bilirubin and creatinine levels Baseline and up to Day 13
Change from Baseline in albumin and total protein levels Baseline and up to Day 13
Change from Baseline in aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase levels Baseline and up to Day 13
Number of subjects with abnormal urinalysis Dipstick results Up to Day 13
Change from Baseline in specific gravity of urine Baseline and up to Day 13
Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) Baseline and up to Day 13
Change from Baseline in pulse rate Baseline and up to Day 13
Change from Baseline in body temperature Baseline and up to Day 13
Enrollment 2055
Condition
Intervention

Intervention Type: Drug

Intervention Name: Gepotidacin

Description: Gepotidacin will be available as tablets containing 750 mg gepotidacin. Each dose should be taken with water after consumption of food.

Arm Group Label: Gepotidacin

Intervention Type: Drug

Intervention Name: Placebo matching nitrofurantoin

Description: Placebo matching nitrofurantoin will be available as over-encapsulated unit-dose capsules. Each dose should be taken with water after consumption of food.

Arm Group Label: Gepotidacin

Intervention Type: Drug

Intervention Name: Nitrofurantoin

Description: 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.

Arm Group Label: Nitrofurantoin

Intervention Type: Drug

Intervention Name: Placebo matching gepotidacin

Description: 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.

Arm Group Label: Nitrofurantoin

Eligibility

Criteria:

Inclusion Criteria: - Subjects having >=12 years of age at the time of signing the informed consent. - Subjects having body weight of >45 kilogram (kg). - Subjects having 2 or more of the following clinical signs and symptoms of acute cystitis with onset <=72 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain. - Subjects having nitrite or pyuria (>15 white blood cells [WBC]/ high power field [HPF] or the presence of 3+/moderate leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures. - Female subjects are included. - Female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance (to abstain from sexual activity to prevent possible re-infection) from the Baseline Visit through completion of the TOC Visit. - Subject is capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)/assent form and in this protocol. Exclusion Criteria: - Subjects reside in a nursing home or dependent care type-facility. - Subject 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 high blood pressure or uncontrolled diabetes. - Subject 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. - Subject is immunocompromised or has altered immune defenses that may predispose the subject to a higher risk of treatment failure and/or complications. For example, uncontrolled diabetes, renal transplant recipients, subjects with clinically significant persistent granulocytopenia (absolute neutrophil count <1000 per microliter [μL]), and subjects receiving immunosuppressive therapy, including corticosteroid therapy [>40 mg per day prednisolone or equivalent for >1 week, >=20 mg per day prednisolone or equivalent for >2 weeks, or prednisolone or equivalent >=10 mg per day for >6 weeks]). Subjects with a known cluster of differentiation 4 (CD4) count of <200 cells per cubic millimeter (cells/mm^3) should not be enrolled. - Subject has a medical condition that requires medication that may be impacted by inhibition of acetylcholinesterase, such as, Poorly controlled asthma or chronic obstructive pulmonary disease at Baseline and, in the opinion of the investigator, not stable on current therapy or acute severe pain, uncontrolled with conventional medical management or active peptic ulcer disease or parkinson disease or myasthenia gravis or a history of seizure disorder requiring medications for control (this does not include a history of childhood febrile seizures) or subject has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study treatment (For example, ileostomy or malabsorption syndrome). - Subject has a known glucose-6-phosphate dehydrogenase deficiency. - Subject, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up. - Subject has a serious underlying disease that could be imminently life-threatening, or the subject is unlikely to survive for the duration of the study period. - Subject 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 Enterobacteriaceae (other than E. coli) as the contributing pathogen. - Subject 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. - Subject has an anatomical or physiological anomaly that predisposes the subject 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, polycystic renal disease), or neurogenic bladder, or the subject has a history of anatomical or functional abnormalities of the urinary tract (for example, chronic vesico-ureteral reflux, detrusor insufficiency). - Subject has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract. - Subject who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI (for example, pyelonephritis, urosepsis), signs and symptom onset >=96 hours before study entry, or a temperature >=101 Degrees Fahrenheit (F), flank pain, chills, or any other manifestations suggestive of upper UTI. - Subject has known anuria, oliguria, or significant impairment of renal function (creatinine clearance <60 mL/min or clinically significant elevated serum creatinine as determined by the investigator). - Subject presents with vaginal discharge at Baseline, for example, suspected sexually transmitted disease. - Subject has congenital long QT syndrome or known prolongation of the corrected QT (QTc) interval. - Subject has uncompensated heart failure. - Subject has severe left ventricular hypertrophy. - Subject has a family history of QT prolongation or sudden death. - Subject has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady-arrhythmia within the last 12 months. - Subject 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 subject is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor or a strong P-glycoprotein (P-gp) inhibitor. - For any subject >=12 to <18 years of age, the subject has an abnormal electrocardiogram (ECG) reading. - Subject has a QTc >450 millisecond (msec) or a QTc >480 msec for subjects with bundle-branch block. - Subject has a documented or recent history of uncorrected hypokalemia within the past 3 months. - Subject has a known alanine aminotransferase (ALT) value >2 times upper limit of normal (ULN). - Subject 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%). - Subject 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). - Subject has a previous history of cholestatic jaundice or hepatic dysfunction associated with nitrofurantoin. - Subject has received treatment with other systemic antimicrobials or systemic antifungals within 1 week before study entry. - Subject must agree not to use the medications or nondrug therapies from the Baseline Visit through the TOC Visit. - Subject has been previously enrolled in this study or has previously been treated with gepotidacin. - Subject has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.

Gender: Female

Gender Based: Yes

Minimum Age: 12 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
GSK Clinical Trials Study Director GlaxoSmithKline
Overall Contact

Last Name: US GSK Clinical Trials Call Center

Phone: 877-379-3718

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator:
GSK Investigational Site | Birmingham, Alabama, 35205, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ronald Orso Principal Investigator
GSK Investigational Site | Birmingham, Alabama, 35235, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Gregory M Flippo Principal Investigator
GSK Investigational Site | Anchorage, Alaska, 99503, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] William Richard Clark Principal Investigator
GSK Investigational Site | Phoenix, Arizona, 85051, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] James L Beach Principal Investigator
GSK Investigational Site | Tucson, Arizona, 85712, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Susan Kalota Principal Investigator
GSK Investigational Site | Chula Vista, California, 91911, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Michael L. Waters Principal Investigator
GSK Investigational Site | La Mesa, California, 91942, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Jeffery Scott Overcash Principal Investigator
GSK Investigational Site | Lomita, California, 90717, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Marina Raikhel Principal Investigator
GSK Investigational Site | Long Beach, California, 90806, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Suzanne Fussell Principal Investigator
GSK Investigational Site | Los Angeles, California, 90602, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] John Kowalczyk Principal Investigator
GSK Investigational Site | Palm Springs, California, 92264, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ann E Stapleton Principal Investigator
GSK Investigational Site | San Diego, California, 92108, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Laurie Han-Conrad Principal Investigator
GSK Investigational Site | Englewood, Colorado, 80113, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Barrett Cowan Principal Investigator
GSK Investigational Site | Middlebury, Connecticut, 06762, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] York Paul Moy Principal Investigator
GSK Investigational Site | DeLand, Florida, 32720, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Godson Oguchi Principal Investigator
GSK Investigational Site | Hialeah, Florida, 33016, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Jose Carpio Principal Investigator
GSK Investigational Site | Miami Springs, Florida, 33166, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Antonio Terrelonge Principal Investigator
GSK Investigational Site | Orlando, Florida, 32806, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Michael E Dever Principal Investigator
GSK Investigational Site | Pompano Beach, Florida, 33060, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Steven Kester Principal Investigator
GSK Investigational Site | Atlanta, Georgia, 30328, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Stephen Blank Principal Investigator
GSK Investigational Site | New Orleans, Louisiana, 70115, United States Completed
GSK Investigational Site | Shreveport, Louisiana, 71106, United States Completed
GSK Investigational Site | Watertown, Massachusetts, 02472, United States Completed
GSK Investigational Site | Albuquerque, New Mexico, 87109, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Frederick J Snoy Principal Investigator
GSK Investigational Site | Endwell, New York, 13760, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Eric Joseph Lorraine Principal Investigator
GSK Investigational Site | Fayetteville, North Carolina, 28303-5537, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Richard Ferro Principal Investigator
GSK Investigational Site | Raleigh, North Carolina, 27612, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Pouru Bhiwandi Principal Investigator
GSK Investigational Site | Scottdale, Pennsylvania, 15683, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Tiffany Pluto Principal Investigator
GSK Investigational Site | Smithfield, Pennsylvania, 15478, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Marcy Goisse Principal Investigator
GSK Investigational Site | West Reading, Pennsylvania, 19611, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Stephen Fehnel Principal Investigator
GSK Investigational Site | Simpsonville, South Carolina, 29681, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Robert E. Broker Principal Investigator
GSK Investigational Site | Memphis, Tennessee, 38120, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] B. Chappell Principal Investigator
GSK Investigational Site | Arlington, Texas, 76014, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Timothy Dao Principal Investigator
GSK Investigational Site | Corpus Christi, Texas, 78414, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Charles Eubank Principal Investigator
GSK Investigational Site | Dallas, Texas, 75209, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Shiwali Rai Principal Investigator
GSK Investigational Site | Houston, Texas, 77055, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Oscar De Valle Principal Investigator
GSK Investigational Site | Humble, Texas, 77338, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Aftab Ahmad Principal Investigator
GSK Investigational Site | Plano, Texas, 75024, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Madhavi Ampajwala Principal Investigator
GSK Investigational Site | Blagoevgrad, 2700, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Tanya Yanakieva Principal Investigator
GSK Investigational Site | Blagoevgrad, 2700, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Petar Uzunov Principal Investigator
GSK Investigational Site | Burgas, 8127, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ditcho Kaloyanov Principal Investigator
GSK Investigational Site | Dupnitsa, 2600, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Hristo Hadzhiyski Principal Investigator
GSK Investigational Site | Lovech, 5500, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Plamenka Dobrevska Principal Investigator
GSK Investigational Site | Pernik, 5800, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Anzhelo Panchev Principal Investigator
GSK Investigational Site | Pleven, 5800, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Lazar Garev Principal Investigator
GSK Investigational Site | Pleven, 5800, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Nikolay Kolev Principal Investigator
GSK Investigational Site | Plovdiv, 4000, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Desislava Gadzheva Principal Investigator
GSK Investigational Site | Sliven, 8800, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Tsanka Ivanova Principal Investigator
GSK Investigational Site | Sliven, 8800, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ivan Ivanov Principal Investigator
GSK Investigational Site | Smolyan, 4700, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Petar Krystanov Principal Investigator
GSK Investigational Site | Sofia, 1000, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Chavdar Slavov Principal Investigator
GSK Investigational Site | Sofia, 1408, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Nader Al Khalil Principal Investigator
GSK Investigational Site | Sofia, 1408, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ziad Al Arbid Principal Investigator
GSK Investigational Site | Sofia, 1431, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Anna Kostadinova Principal Investigator
GSK Investigational Site | Yambol, 8600, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Encho Balabanov Principal Investigator
GSK Investigational Site | Giessen, Hessen, 35385, Germany Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Florian Wagenlehner Principal Investigator
GSK Investigational Site | Essen, Nordrhein-Westfalen, 45355, Germany Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Axel Schaefer Principal Investigator
GSK Investigational Site | Muelheim an der Ruhr, Nordrhein-Westfalen, 45468, Germany Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Elke Stagge Principal Investigator
GSK Investigational Site | Athens, 11525, Greece Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Panagiotis Petrikkos Principal Investigator
GSK Investigational Site | Athens, 15123, Greece Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Athanasios Skoutelis Principal Investigator
GSK Investigational Site | Heraklion, 71110, Greece Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Charalambos Mamoulakis Principal Investigator
GSK Investigational Site | Larisa, 41110, Greece Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Stavros Gravas Principal Investigator
GSK Investigational Site | Thessaloniki, 546 42, Greece Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Emmanuel Roilides Principal Investigator
GSK Investigational Site | Thessaloniki, 54635, Greece Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Dimitrios Hatzichristou Principal Investigator
GSK Investigational Site | Thessaloniki, 56403, Greece Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Konstantinos Hatzimouratidis Principal Investigator
GSK Investigational Site | Csongrád, 6640, Hungary Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Robert Klucsai Principal Investigator
GSK Investigational Site | Debrecen, 4032, Hungary Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Tibor Flasko Principal Investigator
GSK Investigational Site | Kecskemet, 6000, Hungary Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Sandor Hamar Principal Investigator
GSK Investigational Site | Nyíregyháza, 4400, Hungary Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Tarek Ali Principal Investigator
GSK Investigational Site | Orosháza-Szentetornya, 5905, Hungary Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Áron Patvaros Principal Investigator
GSK Investigational Site | Szekszárd, 7100, Hungary Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Attila Szabo Principal Investigator
GSK Investigational Site | Ahmedabad, 380016, India Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Shital Kapadia Principal Investigator
GSK Investigational Site | Gurgaon, 122002, India Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Anurag Khaitan Principal Investigator
GSK Investigational Site | Jaipur, 302004, India Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Dhananjai Agrawal Principal Investigator
GSK Investigational Site | Mumbai, 400053, India Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Sanjay Pandey Principal Investigator
GSK Investigational Site | Surat, 395002, India Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Jagruti Desai Principal Investigator
GSK Investigational Site | Vadodara, 390001, India Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Maitri Shah Principal Investigator
GSK Investigational Site | Varanasi, 221010, India Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Indu Singh Principal Investigator
GSK Investigational Site | Ciudad de Mexico, Campeche, 06100, Mexico Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Matilde Damian Hernandez Principal Investigator
GSK Investigational Site | Guadalajara, Jalisco, 44160, Mexico Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Carlos Alejandro Stobschinski de Alba Principal Investigator
GSK Investigational Site | Guadalajara, Jalisco, 44280, Mexico Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Eduardo Rodriguez Noriega Principal Investigator
GSK Investigational Site | Monterrey, Nuevo León, 64000, Mexico Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Joel Rosas-Sandoval Principal Investigator
GSK Investigational Site | Monterrey, Nuevo León, 64460, Mexico Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Raymundo García-Reza Principal Investigator
GSK Investigational Site | San Juan del Río, Querétaro, 76800, Mexico Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Alejandro Martínez Avendaño Principal Investigator
GSK Investigational Site | Jalisco, 44130, Mexico Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Efrain Montaño Gonzalez Principal Investigator
GSK Investigational Site | Alicante, 03010, Spain Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Pere Llorens Soriano Principal Investigator
GSK Investigational Site | Madrid, 28023, Spain Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ignacio Moncada Principal Investigator
GSK Investigational Site | Madrid, 28041, Spain Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] José Medina Polo Principal Investigator
GSK Investigational Site | Madrid, 28050, Spain Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Pablo Alejandro Cardinal Fernández Principal Investigator
GSK Investigational Site | Valencia, 46026, Spain Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Salvador Guzmán Arlandis Principal Investigator
GSK Investigational Site | Bolton, Nr Manchester, BL3 6TL, United Kingdom Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Paul Nixon Principal Investigator
GSK Investigational Site | Crownhill, Plymouth, PL5 3JB, United Kingdom Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Timothy Hall Principal Investigator
GSK Investigational Site | Liskeard, PL14 3XA, United Kingdom Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Graham Toms Principal Investigator
Location Countries

Bulgaria

Germany

Greece

Hungary

India

Mexico

Spain

United Kingdom

United States

Verification Date

December 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Gepotidacin

Type: Active Comparator

Description: Subjects will be administered oral doses of 1500 mg gepotidacin plus nitrofurantoin matching placebo twice daily (BID); approximately every 12 hours for 5 days

Label: Nitrofurantoin

Type: Active Comparator

Description: Subjects will be administered oral doses of 100 mg nitrofurantoin plus gepotidacin matching placebo BID; approximately every 12 hours for 5 days.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov