Overview

A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the safety and effectiveness of doripenem treatment among Filipino patients with nosocomial pneumonia, complicated intra-abdominal infections, and complicated urinary tract infection.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Pharmaceutica
Criteria
Inclusion Criteria:

- Patients who are diagnosed with nosocomial pneumonia including ventilator-associated
pneumonia, complicated intra-abdominal infections or complicated urinary tract
infection

- Patients who are eligible for doripenem treatment

Exclusion Criteria:

- Pregnant or lactating females

- Patients with hypersensitivity to doripenem and/or its derivatives

- Known at study entry to have an infection caused by pathogen(s) resistant to doripenem

- Patients taking probenecid

- History of severe allergies to certain antibiotics such as penicillins,
cephalosporins, and carbapenems

- Severe impairment of renal function including a calculated creatinine clearance of
less than 10 mL per minute, requirement for peritoneal dialysis, hemodialysis or
hemofiltration, or oliguria (less than 20 mL urine output per hour over 24 hours)