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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Urinary Tract Infections; Pneumonia, Ventilator-Associated
• Intervention / Treatment: Drug: doripenem

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

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 001; doripenem 500mg vial by injection every 8 hours for 5 to 14 days	Drug: doripenem; 500mg vial by injection every 8 hours for 5 to 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With the Usage of Doripenem as Per the Approved Indication	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	5 to 14 days
Number of Participants With Different Mode of Usage of Doripenem		5 to 14 days
Duration of Antibiotic Therapy	Duration of doripenem and duration of doripenem plus oral antibiotics therapy	5 to 14 days
Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score	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.	Baseline (Day -1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.	From Baseline (Day -1) upto the duration of hospital stay of a participant
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)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pte Ltd
• Collaborators: Johnson & Johnson (Hong Kong) Ltd.

Publications and helpful links

General Publications

• Mustafa M, Chan WM, Lee C, Harijanto E, Loo CM, Van Kinh N, Anh ND, Garcia J. A PROspective study on the Usage patterns of Doripenem in the Asia-Pacific region (PROUD study). Int J Antimicrob Agents. 2014 Apr;43(4):353-60. doi: 10.1016/j.ijantimicag.2014.01.017. Epub 2014 Feb 15.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: September 25, 2009
• First Submitted That Met QC Criteria: September 28, 2009
• First Posted (Estimate): September 29, 2009

Study Record Updates

• Last Update Posted (Estimate): February 7, 2013
• Last Update Submitted That Met QC Criteria: January 4, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Urinary tract infection; Doripenem; Doribax; Carbapenem; Nosocomial pneumonia, Intra-abdominal infections
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Urologic Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Infections; Pneumonia; Urinary Tract Infections; Pneumonia, Ventilator-Associated; Anti-Infective Agents; Anti-Bacterial Agents; Doripenem
• Other Study ID Numbers: CR016321; DORIBAC4007 (Other Identifier: Johnson & Johnson Pte Ltd)