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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 4

Conditions

Urinary Tract Infections

Pneumonia, Ventilator-Associated

Pneumonia

Treatments

Drug: doripenem

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00986102

CR016321

DORIBAC4007 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 carbapenem class which is a broad-spectrum antibiotic given to treat patients with serious infections, such as pneumonia and complicated intra-abdominal infections. Physicians in the selected hospital or hospital unit will refer potential patients to the study team. Patients will include men and women 18 years of age and older, hospitalized either in the Intensive Care Unit (ICU) or ward, with a diagnosis of pneumonia, complicated intra-abdominal infections and complicated urinary tract infections. The study has 3 phases: a pretreatment phase with a 1-day screening/baseline visit, a treatment phase of 5 to 14 days, and a post-treatment phase consisting of an end-of-treatment (EOT)/early withdrawal visit to be conducted within 24 hours after the last dose of antimicrobial therapy, a test of cure (TOC) visit 7 to 14 days after EOT, a Day 28 visit, and a post-discharge visit 28 days after discharge from the hospital. Usage of Doripenem in terms of approved indications, mode of usage, duration of antibiotic therapy, and patient characteristics will be assessed. Safety will be assessed through monitoring for adverse events, serial physical examinations, and the collection of conventional laboratory data (chemistry panel, complete blood count with differential). Being a prospective study, patient data will be gathered as the patients are enrolled, starting with their present condition and following them until duration of the study. The study will not compare Doripenem with other antibiotics for the primary endpoint. One vial (500mg) of doripenem intravenously (by injection) every 8 hours for 5 to 14 days

Enrollment

216 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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