PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pte Ltd
• Collaborator: Johnson & Johnson (Hong Kong) Ltd.
• Treatments: Doripenem

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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