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

PHASE3CompletedINTERVENTIONAL
Enrollment

598

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 (80)

Unknown

Research Site, Sylmar

Research Site, Royal Oak

Research Site, Lima

Research Site, Corrientes

Research Site, Córdoba

Research Site, Mendoza

Research Site, Santa Fe

Research Site, Belo Horizonte

Research Site, Campinas/SP

Research Site, Salvador

Research Site, São José Do Rio Preto - SP

Research Site, São Paulo

Research Site, Vila Clementino

Research Site, Pleven

Research Site, Rousse

Research Site, Sofia

Research Site, Zagreb

Research Site, Kyjov

Research Site, Opava

Research Site, Jena

Research Site, Wuppertal

Research Site, Athens

Research Site, Budapest

Research Site, Nagykanizsa

Research Site, Nyíregyháza

Research Site, Zalaegerszeg

Research Site, Jerusalem

Research Site, Petah Tikva

Research Site, Safed

Research Site, Fukuoka

Research Site, Koshigaya-shi

Research Site, Kyoto

Research Site, Nagoya

Research Site, Nara

Research Site, Ōita

Research Site, Sendai

Research Site, Sunto-gun

Research Site, Tokushima

Research Site, Ueda-shi

Research Site, Utsunomiya

Research Site, Guadalajara, Jalisco

Research Site, Inowrocław

Research Site, Krakow

Research Site, Warsaw

Research Site, Lisbon

Research Site, Brasov

Research Site, Bucharest

Research Site, Cluj-Napoca

Research Site, Craiova

Research Site, Iași

Research Site, Arkhangelsk

Research Site, Krasnodar

Research Site, Moscow

Research Site, Novosibirsk

Research Site, Penza

Research Site, Rostov-on-Don

Research Site, Saint Petersburg

Research Site, Saratov

Research Site, Vsevolozhsk

Research Site, Belgrade

Research Site, Kragujevac

Research Site, Poprad

Research Site, Prešov

Research Site, Trnava

Research Site, Žilina

Research Site, Busan

Research Site, Seoul

Research Site, Wŏnju

Research Site, Chiayi City

Research Site, Taipei

Research Site, Diyarbakır

Research Site, Cherkasy

Research Site, Dnipropetrovsk

Research Site, Kharkiv

Research Site, Kyiv

Research Site, Lviv

Research Site, Mykolaiv

Research Site, Odesa

Research Site, Uzhhorod

Research Site, Zaporizhzhya

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Forest Laboratories

INDUSTRY

lead

Pfizer

INDUSTRY