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

Completed · Phase 3

Conditions studied: Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis

In brief

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

Key facts

Study ID

NCT01595438

Run by

Pfizer

People needed

598

Starts

2012-10-01

Expected to finish

2014-08-01

Last updated by the study team

2017-09-06

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 90 years of age inclusive
• Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
• Has pyuria with >/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing >/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem)
• Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis.

You may not qualify if…

• Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem
• Patient's urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
• Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
• Patient is immunocompromised
• Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality

Where it is running

• Research Site — Royal Oak, Michigan, United States
• Research Site — Lima, Ohio, United States
• Research Site — Corrientes, Argentina
• Research Site — Córdoba, Argentina
• Research Site — Mendoza, Argentina
• Research Site — Santa Fe, Argentina
• Research Site — Belo Horizonte, Brazil
• Research Site — Campinas/SP, Brazil
• Research Site — Salvador, Brazil
• Research Site — São José Do Rio Preto - SP, Brazil
• Research Site — São Paulo, Brazil
• Research Site — Vila Clementino, Brazil
• Research Site — Pleven, Bulgaria
• Research Site — Rousse, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Zagreb, Croatia
• Research Site — Kyjov, Czechia
• Research Site — Opava, Czechia
• Research Site — Jena, Germany
• Research Site — Wuppertal, Germany
• Research Site — Athens, Greece
• Research Site — Budapest, Hungary
• Research Site — Nagykanizsa, Hungary
• Research Site — Nyíregyháza, Hungary
• Research Site — Sylmar, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.