NCT01644643 - Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens | Biotech Hunter

Enrollment

345

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions

Complicated Urinary Tract InfectionComplicated Intra-abdominal Infection

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

Best Available Therapy

Patients randomized to receive Best Available Therapy will receive the best available standard of care (SOC) anti-infective therapy for their infection administered in accord with approved local label recommendation

DRUG

Metronidazole

Anti-infective, 500 mg (cIAI only) Patients randomized to receive CAZ-AVI for cIAI will also receive metronidazole (500 mg) administered by IV infusion in a volume of 100 mL at a constant rate over 60 minutes immediately following the CAZ-AVI infusion

Trial Locations (43)

Unknown

Research Site, Shreveport

Research Site, Lima

Research Site, El Talar

Research Site, La Plata

Research Site, Pazardzhik

Research Site, Pleven

Research Site, Rousse

Research Site, Sofia

Research Site, Varna

Research Site, Veliko Tarnovo

Research Site, Slavonski Brod

Research Site, Zagreb

Research Site, Prague

Research Site, Tours

Research Site, Nazareth

Research Site, Petah Tikva

Research Site, Ramat Gan

Research Site, Tel Aviv

Research Site, Guadalajara

Research Site, Mexico City

Research Site, Cusco

Research Site, Surco

Research Site, Manila

Research Site, Szczecin

Research Site, Bucharest

Research Site, Irkutsk

Research Site, Krasnodar

Research Site, Novosibirsk

Research Site, Penza

Research Site, Saint Petersburg

Research Site, Yaroslavl

Research Site, Johannesburg

Research Site, Seoul

Research Site, Barcelona

Research Site, Madrid

Research Site, Ankara

Research Site, Antalya

Research Site, Diyarbakır

Research Site, Istanbul

Research Site, Dnipropetrovsk

Research Site, Kharkiv

Research Site, Kyiv

Research Site, Zaporizhzhya