Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in 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

Urinary tract infections (UTIs; acute cystitis) are very common, with approximately 11 percentage of women (>18 years of age) reporting at least 1 episode of acute cystitis per year. The purpose of this study to evaluate the therapeutic response (combined microbiological and clinical efficacy per participant) of oral gepotidacin compared to oral nitrofurantoin for acute cystitis in adolescent and adult female participants. In this study, participants will be randomly assigned in a 1:1 ratio to receive either oral gepotidacin or oral nitrofurantoin. The study will enroll approximately 2000 participants with uncomplicated UTI. The duration of the study will be approximately 28 days with 4 planned study visits.

Overall Status Recruiting
Start Date April 23, 2020
Completion Date January 13, 2023
Primary Completion Date January 13, 2023
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of participants with therapeutic response at the Test-of-Cure (TOC) visit Up to Day 13
Secondary Outcome
Measure Time Frame
Number of participants with clinical outcome at the TOC visit Up to Day 13
Number of participants with clinical outcome at the follow up visit Up to Day 31
Number of participants with clinical response at the TOC visit Up to Day 13
Number of participants with clinical response at the follow up visit Up to Day 31
Number of participants with microbiological outcome at the TOC visit Up to Day 13
Number of participants with microbiological outcome at the follow up visit Up to Day 31
Number of participants with microbiological response at the TOC visit Up to Day 13
Number of participants with microbiological response at the follow up visit Up to Day 31
Number of participants with therapeutic response at the follow up visit Up to Day 31
Number of participants with treatment-emergent adverse events (AEs) 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 (Giga cells per Liter) Baseline and up to Day 13
Change from Baseline in hemoglobin level (grams per deciliter) Baseline and up to Day 13
Change from Baseline in hematocrit level (Proportion of red blood cells in blood) Baseline and up to Day 13
Change from Baseline in red blood cell (RBC) count (Trillion cells per liter) Baseline and up to Day 13
Change from Baseline in mean corpuscular hemoglobin (MCH) (Picograms) Baseline and up to Day 13
Change from Baseline in mean corpuscular volume (MCV) (Femtoliters) Baseline and up to Day 13
Change from Baseline in blood urea nitrogen (BUN), glucose non-fasting, calcium, chloride, sodium, magnesium, phosphorus, and potassium levels (millimoles per liter) Baseline and up to Day 13
Change from Baseline in total bilirubin, direct bilirubin and creatinine levels (micromoles per Liter) Baseline and up to Day 13
Change from Baseline in albumin and total protein levels (gram per Liter) Baseline and up to Day 13
Change from Baseline in aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase levels (International units per Liter) Baseline and up to Day 13
Number of participants 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
Change from Baseline in PR, QRS, QT, and corrected QT interval (QTc) intervals (milliseconds [msec]) Baseline and up to Day 4
Enrollment 2020
Condition
Intervention

Intervention Type: Drug

Intervention Name: Gepotidacin

Description: Gepotidacin will be available as tablets at a unit dose strength of 750mg. Participants will administer two 750 mg tablets, BID. Each dose will 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. Participants will administer 1 capsule BID. 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 100 mg capsules containing 25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin. Participants will administer one 100 mg capsule, BID. 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. Participants will administer two tablets, BID. Each dose should be taken with water after consumption of food.

Arm Group Label: Nitrofurantoin

Eligibility

Criteria:

Inclusion Criteria: - The participant is >=12 years of age at the time of signing the informed consent/assent and has a body weight >=40 kilogram (kg). - The participant has 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 - The participant has nitrite or pyuria (>15 white blood cell [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. - Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - A female participant is eligible to participate if she is a woman of childbearing potential (WOCBP) who is not pregnant as confirmed by a high sensitivity urine pregnancy test at Baseline (Day 1) regardless of current or prior contraception use or abstinence, is not breastfeeding, or is not a WOCBP. - Additional requirements for pregnancy testing during and after study intervention are specified. - The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. - The participant 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 protocol. 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 a body mass index >=35.0 kg/m^2 and is experiencing obesity-related health conditions such as high blood pressure or uncontrolled diabetes. - The participant has a history of sensitivity to the study interventions, 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. - The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications (e.g., uncontrolled diabetes, renal transplant recipients, participants with clinically significant persistent granulocytopenia [absolute neutrophil count <1000/microliter (μL)], and participants receiving immunosuppressive therapy, including corticosteroid therapy [>40 milligrams (mg)/day prednisolone or equivalent for >1 week, >=20 mg/day prednisolone or equivalent for >2 weeks, or prednisolone or equivalent >=10 mg/day for >6 weeks]). Participants with a known cluster of differentiation 4 (CD4) count of <200 cells per cubic millimeter (cells/mm^3) should not be enrolled. - The participant has any of the following: Medical condition that requires medication that may be impacted by inhibition of acetylcholinesterase, such as; - 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 - Acute severe pain, uncontrolled with conventional medical management - Active peptic ulcer disease - Parkinson disease - Myasthenia gravis - A history of seizure disorder requiring medications for control (this does not include a history of childhood febrile seizures) or - Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention (e.g., ileostomy or malabsorption syndrome) - The participant has a known glucose-6 phosphate dehydrogenase deficiency. - The 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. - 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 Pseudomonas aeruginosa or Enterobacteriaceae (other than Escherichia coli) as the contributing pathogen. - The 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. - The 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 (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). - The participant has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract. - The 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 degree Fahrenheit, flank pain, chills, or any other manifestations suggestive of upper UTI. - The participant has known anuria, oliguria, or significant impairment of renal function (creatinine clearance <60 milliliters per minute (mL/min) or clinically significant elevated serum creatinine as determined by the investigator). - The participant presents with vaginal discharge at Baseline (e.g., suspected sexually transmitted disease). - The participant has congenital long QT syndrome or known prolongation of the 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 symptomatic bradycardia or brady arrhythmia within the last 12 months. - The 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 or a strong P-glycoprotein (P-gp) inhibitor. - For any participant >=12 to <18 years of age, the participant has an abnormal ECG reading at Baseline or during the study intervention. - The participant has a QTc >450 msec or a QTc >480 msec for participants with bundle-branch block. - The participant has a documented or recent history of uncorrected hypokalemia within the past 3 months. - The participant has a known ALT value >2 × upper limit of normal (ULN). - The participant has a known bilirubin value >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - The participant has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice. - The participant has a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. - The participant has received treatment with other systemic antimicrobials or systemic antifungals within 1 week before study entry. - The participant must agree not to use the medications or nondrug therapies from the Baseline Visit through the TOC Visit - The participant has been previously enrolled in this study or has previously been treated with gepotidacin. - The participant 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 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 | Athens, Alabama, 35611, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ernest L Hendrix Principal Investigator
GSK Investigational Site | Homewood, Alabama, 35209, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Austin Lutz Principal Investigator
GSK Investigational Site | Huntsville, Alabama, 35801, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] James McMurray Principal Investigator
GSK Investigational Site | Mobile, Alabama, 36608, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Charles Fox White Principal Investigator
GSK Investigational Site | Gilbert, Arizona, 85296, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Sunildat Maheshwari Principal Investigator
GSK Investigational Site | La Mesa, California, 91942, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Mohamed Bidair Principal Investigator
GSK Investigational Site | Sacramento, California, 95821, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Douglas Glenn Young Principal Investigator
GSK Investigational Site | Washington, District of Columbia, 20011, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Brooke Spencer Principal Investigator
GSK Investigational Site | Boynton Beach, Florida, 33435, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Grant Disick Principal Investigator
GSK Investigational Site | Clearwater, Florida, 33761, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Srikanth Malempati Principal Investigator
GSK Investigational Site | Fleming Island, Florida, 32003, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Michael A Stephens Principal Investigator
GSK Investigational Site | Hialeah, Florida, 33013, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Wilfrido Benitez Principal Investigator
GSK Investigational Site | Jacksonville, Florida, 32205, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Quincy Anne Scarborough Principal Investigator
GSK Investigational Site | Lake Worth, Florida, 33461, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Samuel Lederman Principal Investigator
GSK Investigational Site | Leesburg, Florida, 34748, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Douglas H Moffett Principal Investigator
GSK Investigational Site | Miami, Florida, 33126, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Yamirka Duardo Guerra Principal Investigator
GSK Investigational Site | Miami, Florida, 33135, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Gregory Guell Principal Investigator
GSK Investigational Site | Orlando, Florida, 32810, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Kwabena Ayesu Principal Investigator
GSK Investigational Site | Ormond Beach, Florida, 32174, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] David Westley Carpenter Principal Investigator
GSK Investigational Site | Palm Springs, Florida, 33406, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Luis Carlos Castillo Hernandez Principal Investigator
GSK Investigational Site | Sweetwater, Florida, 33172, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ana Elosegui Principal Investigator
GSK Investigational Site | West Palm Beach, Florida, 33409, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Mira Baron Principal Investigator
GSK Investigational Site | West Palm Beach, Florida, 33409, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ronald T. Ackerman Principal Investigator
GSK Investigational Site | Woodstock, Georgia, 30189, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Bram Derek Wieskopf Principal Investigator
GSK Investigational Site | Blackfoot, Idaho, 83221, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Paul Beckett Principal Investigator
GSK Investigational Site | Boise, Idaho, 83704, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Richard Radnovich Principal Investigator
GSK Investigational Site | Meridian, Idaho, 83642, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Cynthia Ann Fairfax Principal Investigator
GSK Investigational Site | West Des Moines, Iowa, 50266, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Steven Rosenberg Principal Investigator
GSK Investigational Site | El Dorado, Kansas, 67042, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Michael Rausch Principal Investigator
GSK Investigational Site | Wichita, Kansas, 67205, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Tana L Goering Principal Investigator
GSK Investigational Site | Wichita, Kansas, 67207, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Terry D Klein Principal Investigator
GSK Investigational Site | Hanover, Maryland, 21076, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Kaiser Robertson Principal Investigator
GSK Investigational Site | Fall River, Massachusetts, 02723, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Alyssa Kratochvil Principal Investigator
GSK Investigational Site | Cadillac, Michigan, 49601, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] James Diener Principal Investigator
GSK Investigational Site | Butte, Montana, 59701, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] John Pullman Principal Investigator
GSK Investigational Site | Lawrenceville, New Jersey, 08648, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Steven A Sussman Principal Investigator
GSK Investigational Site | Mount Laurel, New Jersey, 08054, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Adam Perzin Principal Investigator
GSK Investigational Site | Albuquerque, New Mexico, 87102, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ellen Kim Principal Investigator
GSK Investigational Site | Binghamton, New York, 13901, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Frank S Eder Principal Investigator
GSK Investigational Site | Brooklyn, New York, 11229, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Michael Yuryev Principal Investigator
GSK Investigational Site | New York, New York, 10016, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Jed C. Kaminetsky Principal Investigator
GSK Investigational Site | Cary, North Carolina, 27518, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Sylvia P Shoffner Principal Investigator
GSK Investigational Site | Mount Airy, North Carolina, 27030, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Eric J Melvin Principal Investigator
GSK Investigational Site | Raleigh, North Carolina, 27612, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Mark Jalkut Principal Investigator
GSK Investigational Site | Wilmington, North Carolina, 28412, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Sandra Liliana Hall Principal Investigator
GSK Investigational Site | Winston-Salem, North Carolina, 27103, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Gregory P. Tarleton Principal Investigator
GSK Investigational Site | Fargo, North Dakota, 58104, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Michael John Lillestol Principal Investigator
GSK Investigational Site | Cincinnati, Ohio, 45215, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Blaise Gatto Principal Investigator
GSK Investigational Site | Cincinnati, Ohio, 45267, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] James Whiteside Principal Investigator
GSK Investigational Site | Columbus, Ohio, 43213, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Harold Green Principal Investigator
GSK Investigational Site | Columbus, Ohio, 43214, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Narinder Saini Principal Investigator
GSK Investigational Site | Columbus, Ohio, 43231, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Milroy Samuel Principal Investigator
GSK Investigational Site | Dayton, Ohio, 45424, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Steve Choi Principal Investigator
GSK Investigational Site | Eugene, Oregon, 97404, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Patricia P Buchanan Principal Investigator
GSK Investigational Site | Bala-Cynwyd, Pennsylvania, 19004, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Laurence H Belkoff Principal Investigator
GSK Investigational Site | Beaver, Pennsylvania, 15009, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Timothy L. Jackson Principal Investigator
GSK Investigational Site | Erie, Pennsylvania, 16507, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Michael Scutella Principal Investigator
GSK Investigational Site | Philadelphia, Pennsylvania, 19107, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Joel P Lebed Principal Investigator
GSK Investigational Site | Anderson, South Carolina, 29621, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Gowdhami Mohan Principal Investigator
GSK Investigational Site | Gaffney, South Carolina, 29340, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] David R Erb Principal Investigator
GSK Investigational Site | Greenville, South Carolina, 29615, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] James E. Wallace Principal Investigator
GSK Investigational Site | Greenville, South Carolina, 29615, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] David Godwin Principal Investigator
GSK Investigational Site | Spartanburg, South Carolina, 29303, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Bang Nguyen Giep Principal Investigator
GSK Investigational Site | Union, South Carolina, 29379, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Joseph A Boscia III Principal Investigator
GSK Investigational Site | Bristol, Tennessee, 37620, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Bernard P. Grunstra Principal Investigator
GSK Investigational Site | Milan, Tennessee, 38358, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Melanie Hoppers Principal Investigator
GSK Investigational Site | Nashville, Tennessee, 37209, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Marc Mickiewicz Principal Investigator
GSK Investigational Site | New Tazewell, Tennessee, 37824-1409, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Charles H DeBusk Principal Investigator
GSK Investigational Site | Austin, Texas, 78704, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Nomita Jairaj Kim Principal Investigator
GSK Investigational Site | Austin, Texas, 78735, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Matthew Brimberry Principal Investigator
GSK Investigational Site | Austin, Texas, 78746, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Michael S Lifshen Principal Investigator
GSK Investigational Site | Austin, Texas, 78758, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Mark Akin Principal Investigator
GSK Investigational Site | Carrollton, Texas, 75010, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Jeffrey G Stewart Principal Investigator
GSK Investigational Site | Houston, Texas, 77061, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Rabia Shaukat Principal Investigator
GSK Investigational Site | Katy, Texas, 77450, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Dilawar Ajani Principal Investigator
GSK Investigational Site | Mesquite, Texas, 75149, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Salma Saiger Principal Investigator
GSK Investigational Site | Missouri City, Texas, 77459, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Deirdre Mcmullen Principal Investigator
GSK Investigational Site | North Richland Hills, Texas, 76180, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Joseph Lambert Principal Investigator
GSK Investigational Site | Plano, Texas, 75024, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Pamela Dione Moore Principal Investigator
GSK Investigational Site | Plano, Texas, 75025, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Douglas Fullington Principal Investigator
GSK Investigational Site | Plano, Texas, 75093, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Heather L Akins Principal Investigator
GSK Investigational Site | Richardson, Texas, 75080, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Bobby Huynh Principal Investigator
GSK Investigational Site | San Antonio, Texas, 78209, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Robert Morin Jr Principal Investigator
GSK Investigational Site | San Antonio, Texas, 78229, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Christopher H. Cantrill Principal Investigator
GSK Investigational Site | San Antonio, Texas, 78251, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Linda Ingeborg Esquivel Principal Investigator
GSK Investigational Site | Bountiful, Utah, 84010, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Allison Hanna Principal Investigator
GSK Investigational Site | Saint George, Utah, 84790, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Joseph H. Woolley Principal Investigator
GSK Investigational Site | Saint George, Utah, 84790, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Jonathon Hubbard Principal Investigator
GSK Investigational Site | Salt Lake City, Utah, 84107, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Stephen F Richardson Principal Investigator
GSK Investigational Site | Midlothian, Virginia, 23114, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Aaron Hartman Principal Investigator
GSK Investigational Site | Richmond, Virginia, 23225, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Gregory Moore Principal Investigator
GSK Investigational Site | Richmond, Virginia, 23235, United States Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ramzi Aboujaoude Principal Investigator
GSK Investigational Site | Bruce, Australian Capital Territory, 2617, Australia Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Amber Leah Principal Investigator
GSK Investigational Site | Blacktown, New South Wales, 2148, Australia Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Christopher Argent Principal Investigator
GSK Investigational Site | Darlinghurst, Sydney, New South Wales, 2010, Australia Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] David Baker Principal Investigator
GSK Investigational Site | Kanwal, New South Wales, 2259, Australia Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Joshua Kim Principal Investigator
GSK Investigational Site | Maroubra, New South Wales, 2035, Australia Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ktut Mark Arya Principal Investigator
GSK Investigational Site | Sydney, New South Wales, 2010, Australia Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Mark Bloch Principal Investigator
GSK Investigational Site | Tarragindi, Queensland, 4121, Australia Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Florence Tiong Principal Investigator
GSK Investigational Site | Herston, 4029, Australia Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] David Paterson Principal Investigator
GSK Investigational Site | Gabrovo, 5300, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Georgi Atanasov Principal Investigator
GSK Investigational Site | Haskovo, 6300, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Vladimir Vladimirov Principal Investigator
GSK Investigational Site | Kyustendil, 2500, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Nikolay Stoyanov Principal Investigator
GSK Investigational Site | Montana, 3400, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Georgi Chakarov Principal Investigator
GSK Investigational Site | Pleven, 5800, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Zhitian Atanasov Principal Investigator
GSK Investigational Site | Ruse, 7000, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ventsislav Georgiev Principal Investigator
GSK Investigational Site | Shumen, 9700, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Dobri Marchev Principal Investigator
GSK Investigational Site | Sofia, 1606, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Boris Mladenov Principal Investigator
GSK Investigational Site | Stara Zagora, 6000, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Emil Petkov Principal Investigator
GSK Investigational Site | Targovisthe, 7700, Bulgaria Recruiting US GSK Clinical Trials Call Center 877-379-3718 [email protected] Ivan Svetulkov Principal Investigator
Location Countries

Australia

Bulgaria

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: Experimental

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

Label: Nitrofurantoin

Type: Active Comparator

Description: Participants 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

Intervention Model Description: This is a parallel study, wherein the participants will be randomized in a 1:1 ratio to receive either gepotidacin 1500 milligram (mg) or nitrofurantoin 100 mg, orally twice daily (BID) for 5 days after food consumption and with water.

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: This is a double blinded study wherein participants and study personnel will be blinded to the allocated intervention.

Source: ClinicalTrials.gov