NCT01763008

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

A Post-Marketing Surveillance Study on the Safety and Effectiveness of Doripenem Among Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 170 (actual)
• Sponsor: Janssen Pharmaceutica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label study (all people know the identity of the treatment assigned), multi-center (conducted at multiple sites), and observational (study in which the investigators/physicians observe the patients and measure their outcomes) study to evaluate the safety and effectiveness of doripenem for the treatment of nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infection among Filipino patients. Safety evaluations for adverse events, clinical laboratory tests, physical examination, and concomitant medications will be monitored throughout the study. The total duration of study for each patient will be approximately for 3 years.

Conditions

• Pneumonia, Bacterial
• Nosocomial Infection
• Intraabdominal Infections
• Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	No intervention	This is an observational study. Doripenem will be administered as per the recommended dose, ie, 500 mg, intravenously (ie, in the vein), for every 8 hours. Duration of treatment with doripenem: for nosocomial pneumonia including ventilator-associated pneumonia patients: 7 to 14 days; for complicated intra-abdominal infection patients: 5 to 14 days; for complicated urinary tract infection, including pyelonephritis (bacterial infection of the kidneys) patients: 10 days.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2013-01-08
• Last updated: 2013-08-09

Locations

4 sites across 1 country: Philippines