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

Phase 4

Completed

Conditions: Pneumonia
Pneumonia, Ventilator-Associated
Urinary Tract Infections

Interventions: Drug: doripenem

Registration Number: NCT00986102

Lead Sponsor: Janssen Research & Development, LLC

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 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 216

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
001	doripenem	doripenem 500mg vial by injection every 8 hours for 5 to 14 days

Primary Outcome Measures

Name	Time	Method
Number of Participants With the Usage of Doripenem as Per the Approved Indication	5 to 14 days	Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization
Number of Participants With Different Mode of Usage of Doripenem	5 to 14 days
Duration of Antibiotic Therapy	5 to 14 days	Duration of doripenem and duration of doripenem plus oral antibiotics therapy
Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score	Baseline (Day -1)	APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 \[less than or equal to 44\] to 6 \[greater than or equal to 75\]) and C: chronic health points (2 \[elective postoperative patient\] and 5 \[non-operative or emergency postoperative patient\]). Total APACHE II score is sum of A, B and C.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)	Day 5 or Day 7 or Day 14
Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit	End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days
Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit	Day 5 or Day 7 or Day 14
Medical Resource Utilization	From Baseline (Day -1) upto the duration of hospital stay of a participant	Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.
Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)	Within 28 days after EOT (Day 5 or Day 7 or Day 14)
Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)	Within 28 days after EOT (Day 5 or Day 7 or Day 14)