Status:
COMPLETED
A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections
Lead Sponsor:
Janssen-Cilag Ltd.,Thailand
Conditions:
Infection
Cross Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
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 treati...
Eligibility Criteria
Inclusion
- Eligibility Criteria:
- Male or female participants with 18 years old age and above
- Diagnosed nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections
- Must have evidence of a systemic inflammatory response syndrome with at least one of the these: fever (body temperature greater than 38 degree celcius) or hypothermia (body temperature less than 36 degree celcius) or elevated total peripheral white blood cell count greater than or equal to 12,000 cells per cubic millimeter or leukopenia with less than 4,000 cells per cubic millimeter or decrease in blood pressure relative to Baseline of greater than 15 millimeter of mercury systolic or increased pulse greater than 100 beats per minute (bpm) and respiratory rates greater than 20 bpm
- Candidate for treatment with carbapenems, with at least one of these conditions: Empirical therapy; suspected infection caused by carbapenem susceptible P. aeruginosa or carbapenem-susceptible A. baumannii or MDR gram negative bacteria or nosocomial infection with failure of previous treatment or modified therapy; known pathogens with resistance to cephalosporins,aminoglycosides, fluoroquinolones or beta-lactam/ batalactamase intibitor and susceptible to carbapenem or known infection caused by gram negative bacteria
- Signed informed consent
Exclusion
- Pregnant or lactating female participants
- History of severe allergies to antibiotics such as penicillins, cephalosporins and carbapenems
- Hypersensitivity to doripenem and/or excipients
- Previous use of carbapenems within 7 days of study entry
- Participants in terminal stage of malignancy
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00965848
Start Date
June 1 2009
End Date
July 1 2010
Last Update
October 30 2013
Active Locations (8)
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1
Bangkok, Thailand
2
Chiang Mai, Thailand
3
Chiang Rai, Thailand
4
Chon Buri, Thailand