NCT00965848

A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Janssen-Cilag Ltd.,Thailand · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of doripenem in participants with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy; pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal (in belly) infections and complicated urinary tract infections (bladder infections).

Detailed description

This is an open-label (all people involved know the identity of the intervention), multi-center (conducted in more than 1 center) study, to evaluate the safety and effectiveness of doripenem in treating Thai participants with nosocomial pneumonia, complicated intra-abdominal and urinary tract infections. The study consists of 4 visits: Visit 1 (Baseline), Visit 2 (End-of-Treatment \[EOT\], up to Day 14), Visit 3 (Phone visit, Test-of-Cure \[TOC\], up to Day 14 after EOT) and Visit 4 (Phone visit, Day 90). Participants will receive 500 milligram (mg) of doripenem as intravenous infusion (directly into the vein) every 8 hours for at least 3 days after clinical response and extended up to 14 days. Efficacy will primarily be evaluated by determination of clinical response. Participants' safety will be monitored throughout the study.

Conditions

• Infection
• Cross Infection
• Bacterial Infections
• Pneumonia, Ventilator-Associated
• Intra-abdominal Infections
• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Doripenem	Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-08-26
• Last updated: 2013-10-30
• Results posted: 2013-08-28

Locations

8 sites across 1 country: Thailand