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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
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).
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Bangkok, Thailand
Chiang Mai, Thailand
Chiang Rai, Thailand
Chon Buri, Thailand
Khon Kaen, Thailand
Nakhon Ratchasima, Thailand
Nakornnayok, Thailand
Pathum Thani, Thailand
Start Date
June 1, 2009
Primary Completion Date
July 1, 2010
Completion Date
July 1, 2010
Last Updated
October 30, 2013
270
ACTUAL participants
Doripenem
DRUG
Lead Sponsor
Janssen-Cilag Ltd.,Thailand
NCT06650501
NCT04929028
Data Source & Attribution
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