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

Pfizer

Status and phase: Completed; Phase 3

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

Treatments: Drug: Ceftazidime - Avibactam ( CAZ-AVI); Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral); Drug: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral); Drug: Doripenem

Study type: Interventional

Funder types: Industry

Identifiers

NCT01599806

2011-005722-21

D4280C00004

Details and patient eligibility

About

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

Full description

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

Enrollment: 641 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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641 participants in 2 patient groups

Ceftazidime - Avibactam ( CAZ-AVI)

Experimental group

Description:

IV treatment

Treatment:

Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)

Drug: Ceftazidime - Avibactam ( CAZ-AVI)

Drug: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)

Doripenem

Active Comparator group

Description:

IV treatment

Treatment:

Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)

Drug: Doripenem

Drug: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)