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
Completed
Trial end date:
2012-11-01
2012-11-01
Target enrollment:
0
0
Participant gender:
All
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?
NoDetails
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)