Overview

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

Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Pfizer
Collaborator:
Forest Laboratories
Treatments:
Avibactam
Avibactam, ceftazidime drug combination
Ceftazidime
Ciprofloxacin
Doripenem
Sulfamethoxazole
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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