Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections

Pfizer

Status and phase: Completed; Phase 2

Conditions: Complicated Urinary Tract Infection

Treatments: Drug: NXL104/ceftazidime; Drug: Imipenem/Cilastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00690378

NXL104/2001

C3591013 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group.

Enrollment: 137 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens

Exclusion criteria

• ileal loops or vesicoureteral reflux
• complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess.
• fungal urinary tract infection
• permanent indirect catheter or nephrostomy unless removed within 48 hours of study entry
• history hypersensitivity to study medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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137 participants in 2 patient groups

1

Experimental group

Description:

NXL/104 ceftazidime

Treatment:

Drug: NXL104/ceftazidime

2

Active Comparator group

Description:

comparator 4 x daily

Treatment:

Drug: Imipenem/Cilastatin