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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,606

Participants

Timeline

Start Date

April 23, 2020

Primary Completion Date

December 1, 2022

Study Completion Date

December 1, 2022

Conditions
Urinary Tract Infections
Interventions
DRUG

Gepotidacin

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.

DRUG

Placebo matching nitrofurantoin

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.

DRUG

Nitrofurantoin

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.

DRUG

Placebo matching gepotidacin

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.

Trial Locations (113)

1606

GSK Investigational Site, Sofia

2010

GSK Investigational Site, Sydney

2035

GSK Investigational Site, Maroubra

2500

GSK Investigational Site, Kyustendil

3400

GSK Investigational Site, Montana

4121

GSK Investigational Site, Tarragindi

5300

GSK Investigational Site, Gabrovo

5800

GSK Investigational Site, Pleven

6000

GSK Investigational Site, Stara Zagora

6300

GSK Investigational Site, Haskovo

7000

GSK Investigational Site, Rousse

7700

GSK Investigational Site, Targovisthe

9700

GSK Investigational Site, Shumen

10016

GSK Investigational Site, New York

10326

GSK Investigational Site, Goyang-si, Gyeonggi-do

10456

GSK Investigational Site, The Bronx

11229

GSK Investigational Site, Brooklyn

15355

GSK Investigational Site, Ansan-si

16247

GSK Investigational Site, Suwon

19004

GSK Investigational Site, Bala-Cynwyd

19107

GSK Investigational Site, Philadelphia

20011

GSK Investigational Site, Washington D.C.

21076

GSK Investigational Site, Hanover

21565

GSK Investigational Site, Incheon

23225

GSK Investigational Site, Richmond

23235

GSK Investigational Site, Richmond

27103

GSK Investigational Site, Winston-Salem

27518

GSK Investigational Site, Cary

28412

GSK Investigational Site, Wilmington

29379

GSK Investigational Site, Union

29615

GSK Investigational Site, Greenville

29720

GSK Investigational Site, Lancaster

32174

GSK Investigational Site, Ormond Beach

32607

GSK Investigational Site, Gainesville

32810

GSK Investigational Site, Orlando

33013

GSK Investigational Site, Hialeah

33063

GSK Investigational Site, Coconut Creek

33126

GSK Investigational Site, Miami

33135

GSK Investigational Site, Miami

33155

GSK Investigational Site, Miami

33172

GSK Investigational Site, Sweetwater

33406

GSK Investigational Site, Palm Springs

33409

GSK Investigational Site, West Palm Beach

33435

GSK Investigational Site, Boynton Beach

33461

GSK Investigational Site, Lake Worth

33563

GSK Investigational Site, Plant City

33572

GSK Investigational Site, Apollo Beach

33614

GSK Investigational Site, Tampa

33761

GSK Investigational Site, Clearwater

34748

GSK Investigational Site, Leesburg

35205

GSK Investigational Site, Birmingham

35209

GSK Investigational Site, Homewood

35801

GSK Investigational Site, Huntsville

38358

GSK Investigational Site, Milan

43213

GSK Investigational Site, Columbus

43214

GSK Investigational Site, Columbus

43231

GSK Investigational Site, Columbus

45215

GSK Investigational Site, Cincinnati

45424

GSK Investigational Site, Dayton

58104

GSK Investigational Site, Fargo

58128

GSK Investigational Site, Hwasun-gun, Jeollanam-do

59701

GSK Investigational Site, Butte

68510

GSK Investigational Site, Lincoln

75024

GSK Investigational Site, Plano

75149

GSK Investigational Site, Mesquite

76180

GSK Investigational Site, North Richland Hills

77087

GSK Investigational Site, Houston

77450

GSK Investigational Site, Katy

77459

GSK Investigational Site, Missouri City

78209

GSK Investigational Site, San Antonio

78229

GSK Investigational Site, San Antonio

78251

GSK Investigational Site, San Antonio

78735

GSK Investigational Site, Austin

83221

GSK Investigational Site, Blackfoot

83642

GSK Investigational Site, Meridian

83704

GSK Investigational Site, Boise

84010

GSK Investigational Site, Bountiful

84107

GSK Investigational Site, Salt Lake City

84790

GSK Investigational Site, St. George

85296

GSK Investigational Site, Gilbert

91324

GSK Investigational Site, Northridge

91942

GSK Investigational Site, La Mesa

95821

GSK Investigational Site, Sacramento

97404

GSK Investigational Site, Eugene

110062

GSK Investigational Site, New Delhi

360005

GSK Investigational Site, Rajkot

395010

GSK Investigational Site, Surat

400022

GSK Investigational Site, Mumbai

411016

GSK Investigational Site, Pune

422101

GSK Investigational Site, Nashik

431001

GSK Investigational Site, Aurangabad

440003

GSK Investigational Site, Nagpur

440015

GSK Investigational Site, Nagpur

442402

GSK Investigational Site, Chandrapur

500004

GSK Investigational Site, Hyderabad

85381-3689

GSK Investigational Site, Peoria

85015-1104

GSK Investigational Site, Phoenix

95350-5365

GSK Investigational Site, Modesto

91355-5319

GSK Investigational Site, Valencia

33186-2178

GSK Investigational Site, Miami

33026-4383

GSK Investigational Site, Pembroke Pines

02723

GSK Investigational Site, Fall River

07018-1502

GSK Investigational Site, East Orange

08648

GSK Investigational Site, Lawrenceville

08054

GSK Investigational Site, Mount Laurel

10016-7313

GSK Investigational Site, New York

37824-1409

GSK Investigational Site, New Tazewell

78744 -1645

GSK Investigational Site, Austin

40-748

GSK Investigational Site, Katowice

27-400

GSK Investigational Site, Ostrowiec Świętokrzyski

21-040

GSK Investigational Site, Świdnik

02798

GSK Investigational Site, Warsaw

06973

GSK Investigational Site, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT04187144 - Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI) | Biotech Hunter | Biotech Hunter