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

CompletedPhase 4

Sponsor: Janssen Research & Development, LLC

Conditions: Pneumonia, Pneumonia, Ventilator-Associated, Urinary Tract Infections

Interventions: doripenem

Countries: Hong Kong, Indonesia, Malaysia, Singapore, Vietnam

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (16)

Hong Kong, Hong Kong
Bandung, Indonesia
Jakarta, Indonesia
Surabaya, Indonesia
Ipoh, Malaysia
Johor Bahru, Malaysia
Kota Bharu, Malaysia
Kuala Lumpur, Malaysia
Kuala Lumpur K Lumpur, Malaysia
Kuala Selangor, Malaysia
Pulau Pinang, Malaysia
Seremban, Malaysia
Terengganu, Malaysia
Singapore, Singapore
Hanoi, Vietnam
Ho Chi Minh City, Vietnam