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