Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections

PHASE3CompletedINTERVENTIONAL
Enrollment

661

Participants

Timeline

Start Date

August 7, 2019

Primary Completion Date

December 14, 2021

Study Completion Date

December 14, 2021

Conditions
Urinary Tract InfectionsAcute Pyelonephritis
Interventions
DRUG

Cefepime/VNRX-5133 (taniborbactam)

Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.

DRUG

Meropenem

Meropenem will be administered q8h IV over 30 minutes for 7 days (up to 14 days for patients with bacteremia). Patients will also receive cefepime/VNRX-5133 placebo administered via IV over a 2-hour period.

Trial Locations (78)

29

Site 160410, Lima

41

Site 160406, Lima

84

Site 160403, Cuzco

1204

Site 134801, Budapest

1407

Site 110010, Sofia

1606

Site 110004, Sofia

Site 110005, Sofia

Site 110008, Sofia

4003

Site 110007, Plovdiv

4400

Site 134803, Nyíregyháza

5000

Site 110001, Veliko Tarnovo

5300

Site 110009, Gabrovo

5800

Site 110002, Pleven

6111

Site 180402, Kharkiv

6725

Site 134804, Szeged

7002

Site 110003, Rousse

10000

Site 119101, Zagreb

Site 119106, Zagreb

11000

Site 189001, Belgrade

11080

Site 189002, Belgrade

21000

Site 119103, Split

21018

Site 180403, Vinnytsia

21280

Site 179204, Diyarbakır

28018

Site 148402, Colima

35040

Site 179203, Bornova

43000

Site 180401, Lutsk

44280

Site 148401, Guadalajara

49005

Site 180404, Dnipro

54100

Site 179207, Adapazarı

61080

Site 179202, Bostancı

69600

Site 180407, Zaporizhzhya

76014

Site 180408, Ivano-Frankivsk

90620

Site 184003, Buena Park

91324

184012, Northridge

91911

Site 184002, Chula Vista

91942

Site 184001, La Mesa

100034

Site 156002, Beijing

100050

Site 156006, Beijing

116023

Site 156004, Dalian

117593

Site 164307, Moscow

156005

Site 156005, Nanjing

194044

Site 164303, Saint Petersburg

200025

Site 156017, Shanghai

200642

Site 164201, Craiova

210008

Site 156008, Nanjing

210009

Site 156007, Nanjing

276000

Site 156028, Shandong

300192

Site 156020, Tianjin

315010

Site 156013, Ningbo

330006

Site 156003, Nanchang

344011

Site 164311, Rostov-on-Don

357500

Site 164308, Pyatigorsk

361003

Site 156010, Xiamen

362202

Site 156030, Fujian

400016

Site 156011, Chongqing

400038

Site 156012, Chongqing

410054

Site 164302, Saratov

440026

Site 164301, Penza

510120

Site 156025, Guangzhou

515041

Site 156014, Guangdong

518035

Site 156027, Guangdong

550002

Site 156018, Guiyang

610041

Site 156015, Chendu

830054

Site 156029, Ürümqi

X5016KEH

Site 103203, Córdoba

30150-221

Site 107601, Belo Horizonte

04039-901

Site 107608, São Paulo

014010

Site 156022, Baotou

050000

Site 156016, Shijiazhuang

LV-5417

Site 142803, Daugavpils

LV-1002

Site 142804, Riga

LV-1038

Site 142801, Riga

TRUJ 01

Site 160404, Trujillo

010825

Site 164206, Bucharest

020125

Site 164205, Bucharest

050653

Site 164204, Bucharest

06800

Site 179205, Çankaya

02125

Site 180406, Kyiv

All Listed Sponsors
lead

Venatorx Pharmaceuticals, Inc.

INDUSTRY

NCT03840148 - Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections | Biotech Hunter | Biotech Hunter