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)