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

A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group,
Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime
Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy
in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis,
With a Gram Negative Pathogen in Hospitalized Adults

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