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)
Who is this study for? Child to adult female patients with Acute Cystitis
What treatments are being studied? Gepotidacin
Status: Completed
Location: See all (112) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 12
Healthy Volunteers: f
View:
• 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 \<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 leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures.
• The participant is female.
• The participant is capable of giving signed informed consent/assent.
Locations
United States
Alabama
GSK Investigational Site
Birmingham
GSK Investigational Site
Homewood
GSK Investigational Site
Huntsville
Arizona
GSK Investigational Site
Gilbert
GSK Investigational Site
Peoria
GSK Investigational Site
Phoenix
California
GSK Investigational Site
La Mesa
GSK Investigational Site
Modesto
GSK Investigational Site
Northridge
GSK Investigational Site
Sacramento
GSK Investigational Site
Valencia
Washington, D.c.
GSK Investigational Site
Washington
Florida
GSK Investigational Site
Apollo Beach
GSK Investigational Site
Boynton Beach
GSK Investigational Site
Clearwater
GSK Investigational Site
Coconut Creek
GSK Investigational Site
Gainesville
GSK Investigational Site
Hialeah
GSK Investigational Site
Lake Worth
GSK Investigational Site
Leesburg
GSK Investigational Site
Miami
GSK Investigational Site
Miami
GSK Investigational Site
Miami
GSK Investigational Site
Miami
GSK Investigational Site
Orlando
GSK Investigational Site
Ormond Beach
GSK Investigational Site
Palm Springs
GSK Investigational Site
Pembroke Pines
GSK Investigational Site
Plant City
GSK Investigational Site
Sweetwater
GSK Investigational Site
Tampa
GSK Investigational Site
West Palm Beach
Idaho
GSK Investigational Site
Blackfoot
GSK Investigational Site
Boise
GSK Investigational Site
Meridian
Massachusetts
GSK Investigational Site
Fall River
Maryland
GSK Investigational Site
Hanover
Montana
GSK Investigational Site
Butte
North Carolina
GSK Investigational Site
Cary
GSK Investigational Site
Wilmington
GSK Investigational Site
Winston-salem
North Dakota
GSK Investigational Site
Fargo
Nebraska
GSK Investigational Site
Lincoln
New Jersey
GSK Investigational Site
East Orange
GSK Investigational Site
Lawrenceville
GSK Investigational Site
Mount Laurel
New York
GSK Investigational Site
Bronx
GSK Investigational Site
Brooklyn
GSK Investigational Site
New York
Ohio
GSK Investigational Site
Cincinnati
GSK Investigational Site
Columbus
GSK Investigational Site
Columbus
GSK Investigational Site
Columbus
GSK Investigational Site
Dayton
Oregon
GSK Investigational Site
Eugene
Pennsylvania
GSK Investigational Site
Bala-cynwyd
GSK Investigational Site
Philadelphia
South Carolina
GSK Investigational Site
Greenville
GSK Investigational Site
Lancaster
GSK Investigational Site
Union
Tennessee
GSK Investigational Site
Milan
GSK Investigational Site
New Tazewell
Texas
GSK Investigational Site
Austin
GSK Investigational Site
Austin
GSK Investigational Site
Houston
GSK Investigational Site
Katy
GSK Investigational Site
Mesquite
GSK Investigational Site
Missouri City
GSK Investigational Site
North Richland Hills
GSK Investigational Site
Plano
GSK Investigational Site
San Antonio
GSK Investigational Site
San Antonio
GSK Investigational Site
San Antonio
Utah
GSK Investigational Site
Bountiful
GSK Investigational Site
Saint George
GSK Investigational Site
Salt Lake City
Virginia
GSK Investigational Site
Richmond
GSK Investigational Site
Richmond
Other Locations
Australia
GSK Investigational Site
Maroubra
GSK Investigational Site
Sydney
GSK Investigational Site
Tarragindi
Bulgaria
GSK Investigational Site
Gabrovo
GSK Investigational Site
Haskovo
GSK Investigational Site
Kyustendil
GSK Investigational Site
Montana
GSK Investigational Site
Pleven
GSK Investigational Site
Ruse
GSK Investigational Site
Shumen
GSK Investigational Site
Sofia
GSK Investigational Site
Stara Zagora
GSK Investigational Site
Targovisthe
India
GSK Investigational Site
Aurangabad
GSK Investigational Site
Chandrapur
GSK Investigational Site
Hyderabad
GSK Investigational Site
Mumbai
GSK Investigational Site
Nagpur
GSK Investigational Site
Nagpur
GSK Investigational Site
Nashik
GSK Investigational Site
New Delhi
GSK Investigational Site
Pune
GSK Investigational Site
Rajkot
GSK Investigational Site
Surat
Poland
GSK Investigational Site
Katowice
GSK Investigational Site
Ostrowiec Swietokrzyski
GSK Investigational Site
Swidnik
GSK Investigational Site
Warszawa
Republic of Korea
GSK Investigational Site
Ansan-si
GSK Investigational Site
Goyang-si, Gyeonggi-do
GSK Investigational Site
Hwasun-gun, Jeollanam-do
GSK Investigational Site
Incheon
GSK Investigational Site
Seoul
GSK Investigational Site
Suwon
Time Frame
Start Date: 2020-04-23
Completion Date: 2022-12-01
Participants
Target number of participants: 1606
Treatments
Experimental: Gepotidacin
Participants will be administered oral doses of 1500 milligrams (mg) gepotidacin plus nitrofurantoin matching placebo BID; approximately every 12 hours for 5 days.
Active_comparator: Nitrofurantoin
Participants will be administered oral doses of 100 mg nitrofurantoin plus gepotidacin matching placebo BID; approximately every 12 hours for 5 days.
Authors
Georgi Atanasov, Ronald T Ackerman, Aaron Hartman, Deirdre Mcmullen, Milroy Samuel, Allen A Freestone, Suchet R Patel, Kwabena Ayesu, David Westley Carpenter, Steven Rosenberg, Grant Disick, Mark Jalkut, Jennifer Sobol, Christopher H. Cantrill, Pamela Dione Moore, Terry D Klein, Steven A Sussman, Linda Ingeborg Esquivel, Joel P Lebed, Michael A Stephens, Gowdhami Mohan, Gregory Moore, Mark Bloch, Caroline Mbogua, Rabia Shaukat, James Diener, Quincy Anne Scarborough, Sandra Liliana Hall, Adekunle Adeoti, James E. Wallace, Laurence H Belkoff, Jesus Navarro, Heather L Akins, Wilfrido Benitez, Kaiser Robertson, Marc Mickiewicz, Ernest L Hendrix, Srikanth Malempati, James McMurray, Dilawar Ajani, Eric J Melvin, Craig Boyle, Joseph H. Woolley, Samuel Lederman, Blaise Gatto, Douglas Fullington, Alyssa Kratochvil, Austin Lutz, Mira Baron, Michael Scutella, Scott P Striplin, Michael Yuryev, Bang Nguyen Giep, Richard Radnovich, Bernard P. Grunstra, Adam Perzin, Michael S Lifshen, Robin Kroll, Gregory P. Tarleton, Douglas Glenn Young, Jed C. Kaminetsky, Nomita Jairaj Kim, Ana Elosegui, Timothy L. Jackson, David Godwin, Curtis Dunshee, David R Erb, Tana L Goering, Frank S Eder, Tyler J Adam, Mohamed Bidair, Ramzi Aboujaoude, Melanie Hoppers, David D DeAtkine, Mark Akin, James Whiteside, Walter Faggett, Paul Beckett, Jay Meyer, Ellen Kim, Nastran Hashemi, John Pullman, Michael F Carter, Joseph A Boscia III, Michael Rausch, Sunildat Maheshwari, Won Yeol Cho, Bram Derek Wieskopf, Amrendra Kumar, Allison Hanna, Douglas H Moffett, Jeffrey G Stewart, Bobby Huynh, Gregory Guell, Frederick J Ast, Michael John Lillestol, Patricia P Buchanan, Sylvia P Shoffner, Łukasz Curyło, Boris Mladenov, Mariusz Kiecka, Kwang Taek Kim, Piotr Radziszewski, Pawel Miotla
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline