Status:
COMPLETED
PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
Johnson & Johnson (Hong Kong) Ltd.
Conditions:
Pneumonia
Pneumonia, Ventilator-Associated
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to understand the utilization patterns of doripenem in Asia Pacific, including the profile of the patients treated with carbapenems.
Detailed Description
This is a Phase 4, prospective, open-label, non-comparative, multicenter study to characterize the usage of doripenem in selected hospitals in the Asia Pacific region. Doripenem belongs to the carbape...
Eligibility Criteria
Inclusion
- Patients hospitalized either in the ICU or ward, with a diagnosis of pneumonia, complicated abdominal infections, or complicated urinary tract infection using the protocol-defined Guidelines for Diagnosis
Exclusion
- Pregnant or lactating females
- Allergies to Doripenem or its derivatives
- Infected by a bacteria that is resistant to Doripenem
- Taking probenecid
- Severe allergies to other antibiotics like penicillins, cephalosporins, or carbapenems
- Severe kidney disease, in an unstable disease state and assessed as unlikely to survive until the study follow up period
- Signs of severe sepsis with treatment failure with other carbapenems, who received other carbapenem within 2 weeks before first dose of study drug, and who has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements
Key Trial Info
Start Date :
July 17 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2011
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00986102
Start Date
July 17 2009
End Date
September 9 2011
Last Update
November 19 2024
Active Locations (16)
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1
Hong Kong, Hong Kong
2
Bandung, Indonesia
3
Jakarta, Indonesia
4
Surabaya, Indonesia