A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,690

Participants

Timeline

Start Date

December 21, 2023

Primary Completion Date

January 18, 2025

Study Completion Date

February 6, 2025

Conditions
Urinary Tract InfectionAcute Pyelonephritis
Interventions
DRUG

TBP-PI-HBr

TBP-PI-HBr film-coated immediate-release tablets.

DRUG

Imipenem-cilastatin

Sterile powder for reconstitution administered as IV.

DRUG

Dummy Infusion

0.9% sodium chloride administered as IV infusion.

DRUG

Dummy Tablets

TBP-PI-HBr matching dummy tablets.

Trial Locations (84)

33144

Medical facility, Miami

33176

Medical Facility, Miami

Unknown

Medical Facility, Buenos Aires

Medical Facility, Córdoba

Medical Facility, La Plata

Medical Facility, Mendoza

Medical Facility, San Miguel de Tucumán

Medical Facility, Villa Regina

Medical Facility, Banja Luka

Medical Facility, Sarajevo

Medical Facility, Tuzla

Medical Facility, Barueri

Medical Facility, Campinas

Medical Facility, Curitiba

Medical Facility, Porto Alegre

Medical Facility, São José do Rio Preto

Medical Facility, Blagoevgrad

Medical Facility, Dobrich

Medical Facility, Gabrovo

Medical facility, Lom

Medical Facility, Pleven

Medical Facility, Plovdiv

Medical facility, Rousse

Medical facility, Shumen

Medical Facility, Sliven

Medical facility, Sofia

Medical Facility, Varna

Medical Facility, Čakovec

Medical Facility, Slavonski Brod

Medical Facility, Split

Medical Facility, Zagreb

Medical Facility, Kohtla-Järve

Medical Facility, Pärnu

Medical Facility, Tallinn

Medical Facility, Võru

Medical facility, Tbilisi

Medical Facility, Alexandroupoli

Medical Facility, Athens

Medical Facility, Ioannina

Medical Facility, Pátrai

Medical Facility, Thessaloniki

Medical Facility, Budapest

Medical Facility, Eger

Medical Facility, Kistarcsa

Medical Facility, Nyíregyháza

Medical Facility, Varanasi

Medical Facility, Bangalore

Medical Facility, Belagavi

Medical Facility, Jaipur

Medical Facility, Lucknow

Medical Facility, Daugavpils

Medical Facility, Liepāja

Medical Facility, Riga

Medical Facility, Valmiera

Medical Facility, Chisinau

Medical Facility, Krakow

Medical Facility, Lodz

Medical Facility, Warsaw

Medical Facility, Łęczna

Medical Facility, Brasov

Medical facility, Bucharest

Medical facility, Craiova

Medical Facility, Iași

Medical Facility, Oradea

Medical Facility, Timișoara

Medical facility, Belgrade

Medical facility, Kragujevac

Medical facility, Niš

Medical facility, Novi Sad

Medical Facility, Bratislava

Medical Facility, Galanta

Medical Facility, Lučenec

Medical Facility, Malacky

Medical Facility, Poprad

Medical facility, Benoni

Medical facility, Durban

Medical Facility, Pretoria

Medical Facility, Tongaat

Medical Facility, Umhlanga

Medical Facility, Ankara

Medical Facility, Diyarbakır

Medical Facility, Istanbul

Medical Facility, Izmir

Medical Facility, Samsun

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Spero Therapeutics

INDUSTRY