Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,372

Participants

Timeline

Start Date

June 3, 2019

Primary Completion Date

May 20, 2020

Study Completion Date

May 27, 2020

Conditions
Complicated Urinary Tract InfectionAcute Pyelonephritis
Interventions
DRUG

TBPM-PI-HBr

TBPM-PI-HBr tablets administered orally.

DRUG

Ertapenem

Antibiotic Therapy for cUTI.

DRUG

Dummy Infusion

Dummy intravenous infusion.

DRUG

Dummy tablets

Dummy tablets orally.

Trial Locations (96)

1050

Medical Facility, Middelburg

1431

Medical Facility, Sofia

1500

Medical Facility, Benoni

1606

Medical Facility, Sofia

2000

Medical Facility, Zestaponi

2013

Medical Facility, Johannesburg

2700

Medical Facility, Blagoevgrad

2800

Medical Facility, Tatabánya

4001

Medical Facility, Durban

4092

Medical Facility, Chatsworth

4400

Medical Facility, Nyíregyháza

5000

Medical Facility, Veliko Tarnovo

7000

Medical Facility, Rousse

9300

Medical Facility, Dobrich

9700

Medical Facility, Shumen

10002

Medical Facility, Zhytomyr

10617

Medical Facility, Tallinn

11080

Medical Facility, Belgrade

14034

Medical Facility, Chernihiv

18009

Medical Facility, Cherkasy

21018

Medical Facility, Vinnytsia

26300

Medical Facility, Vršac

31025

Medical Facility, Kohtla-Järve

33144

Medical Facility, Miami

49027

Medical Facility, Dnipro

54058

Medical Facility, Mykolaiv

61037

Medical Facility, Kharkiv

61103

Medical Facility, Kharkiv

65025

Medical Facility, Odesa

65074

Medical Facility, Odesa

65526

Medical Facility, Võru

69600

Medical Facility, Zaporizhia

76008

Medical Facility, Ivano-Frankivsk

76018

Medical Facility, Ivano-Frankivsk

79010

Medical Facility, Lviv

79059

Medical Facility, Lviv

88000

Medical Facility, Uzhhorod

91942

Medical Facility, La Mesa

150062

Medical Facility, Yaroslavl

163001

Medical Facility, Arkhangelsk

188643

Medical Facility, Vsevolozhsk

191186

Medical Facility, Saint Petersburg

193312

Medical Facility, Saint Petersburg

194017

Medical Facility, Saint Petersburg

194044

Medical Facility, Saint Petersburg

194064

Medical Facility, Saint Petersburg

195009

Medical Facility, Saint Petersburg

195067

Medical Facility, Saint Petersburg

196247

Medical Facility, Saint Petersburg

197022

Medical Facility, Saint Petersburg

197374

Medical Facility, Saint Petersburg

198205

Medical Facility, Saint Petersburg

198412

Medical Facility, Lomonosov

199106

Medical facility, Saint Petersburg

200642

Medical Facility, Craiova

214019

Medical Facility, Smolensk

214025

Medical Facility, Smolensk

357500

Medical Facility, Pyatigorsk

410469

Medical Facility, Oradea

440026

Medical Facility, Penza

700503

Medical Facility, Iași

360 66

Medical Facility, Karlovy Vary

460 63

Medical Facility, Liberec

140 59

Medical Facility, Prague

401 13

Medical Facility, Ústí nad Labem

762 75

Medical Facility, Zlín

0144

Medical Facility, Tbilisi

0159

Medical Facility, Tbilisi

0160

Medical Facility, Tbilisi

0172

Medical Facility, Tbilisi

H-1082

Medical Facility, Budapest

H-1204

Medical Facility, Budapest

H-8800

Medical Facility, Nagykanizsa

LV-1002

Medical Facility, Riga

LV-1038

Medical Facility, Riga

LV-4201

Medical Facility, Valmiera

MD-2004

Medical Facility, Chisinau

MD2025

Medical Facility, Chisinau

40-211

Medical Facility, Katowice

31-559

Medical Facility, Krakow

90-153

Medical Facility, Lodz

32-600

Medical Facility, Oświęcim

51-162

Medical Facility, Wroclaw

020125

Medical Facility, Bucharest

021494

Medical Facility, Bucharest

050659

Medical Facility, Bucharest

11 000

Medical Facility, Belgrade

34 000

Medical Facility, Kragujevac

21 000

Medical Facility, Novi Sad

826 06

Medical Facility, Bratislava

924 22

Medical Facility, Galanta

984 01

Medical Facility, Lučenec

03659

Medical Facility, Martin

05845

Medical Facility, Poprad

089 01

Medical Facility, Svidník

0001

Medical Facility, Pretoria

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Spero Therapeutics

INDUSTRY

NCT03788967 - Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) | Biotech Hunter | Biotech Hunter