Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

PHASE3CompletedINTERVENTIONAL
Enrollment

641

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Interventions
DRUG

Ceftazidime - Avibactam ( CAZ-AVI)

Ceftazidime 2000 mg and 500 mg of avibactam. Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes

DRUG

Doripenem

500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes

DRUG

Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)

Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement

DRUG

or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)

Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement

Trial Locations (57)

Unknown

Research Site, Detroit

Research Site, St Louis

Research Site, Indiana

Research Site, Rosario

Research Site, Pazardzhik

Research Site, Sofia

Research Site, Veliko Tarnovo

Research Site, Slavonski Brod

Research Site, Zadar

Research Site, Zagreb

Research Site, Liberec

Research Site, Prague

Research Site, Hamburg

Research Site, Haifa

Research Site, Kfar Saba

Research Site, Modena

Research Site, Cuernavaca, MOR

Research Site, Guadalajara

Research Site, Zapopan

Research Site, Arequipa

Research Site, Cercardo de Lima

Research Site, Cusco

Research Site, Lima

Research Site, Trujillo

Research Site, Bialystok

Research Site, Sochaczew

Research Site, Wroclaw

Research Site, Bucharest

Research Site, Oradea

Research Site, Sibiu

Research Site, Timișoara

Research Site, Moscow

Research Site, Nizhny Novgorod

Research Site, Novosibirsk

Research Site, Saint Petersburg

Research Site, Smolensk

Research Site, Tomsk

Research Site, Veliky Novgorod

Research Site, Busan

Research Site, Jeonnam

Research Site, Seoul

Research Site, Alicante

Research Site, Alzira (Valencia)

Research Site, Barcelona

Research Site, Elche

Research Site, Granada

Research Site, Terrassa

Research Site, Kaohsiung City

Research Site, Taipei

Research Site, Chernivtsi

Research Site, Ivano-Frankivsk

Research Site, Kharkiv

Research Site, Kyiv

Research Site, Lutsk

Research Site, Simferopol

Research Site, Vinnytsia

Research Site, Zaporizhzhya

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Forest Laboratories

INDUSTRY

lead

Pfizer

INDUSTRY