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

Primary Purpose

Pneumonia, Pneumonia, Ventilator-Associated, Urinary Tract Infections

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
doripenem
Sponsored by
Johnson & Johnson Pte Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Carbapenem, Doripenem, Doribax, Nosocomial pneumonia, Intra-abdominal infections, Urinary tract infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

001

Arm Description

doripenem 500mg vial by injection every 8 hours for 5 to 14 days

Outcomes

Primary Outcome Measures

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
Number of Participants With Different Mode of Usage of Doripenem
Duration of Antibiotic Therapy
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
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

Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)
Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit
Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit
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.
Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)
Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)

Full Information

First Posted
September 25, 2009
Last Updated
January 4, 2013
Sponsor
Johnson & Johnson Pte Ltd
Collaborators
Johnson & Johnson (Hong Kong) Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00986102
Brief Title
PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
Official Title
A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johnson & Johnson Pte Ltd
Collaborators
Johnson & Johnson (Hong Kong) Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumonia, Ventilator-Associated, Urinary Tract Infections
Keywords
Carbapenem, Doripenem, Doribax, Nosocomial pneumonia, Intra-abdominal infections, Urinary tract infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
001
Arm Type
Other
Arm Description
doripenem 500mg vial by injection every 8 hours for 5 to 14 days
Intervention Type
Drug
Intervention Name(s)
doripenem
Intervention Description
500mg vial by injection every 8 hours for 5 to 14 days
Primary Outcome Measure Information:
Title
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Description
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
Time Frame
5 to 14 days
Title
Number of Participants With Different Mode of Usage of Doripenem
Time Frame
5 to 14 days
Title
Duration of Antibiotic Therapy
Description
Duration of doripenem and duration of doripenem plus oral antibiotics therapy
Time Frame
5 to 14 days
Title
Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Description
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.
Time Frame
Baseline (Day -1)
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)
Time Frame
Day 5 or Day 7 or Day 14
Title
Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit
Time Frame
End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days
Title
Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit
Time Frame
Day 5 or Day 7 or Day 14
Title
Medical Resource Utilization
Description
Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.
Time Frame
From Baseline (Day -1) upto the duration of hospital stay of a participant
Title
Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)
Time Frame
Within 28 days after EOT (Day 5 or Day 7 or Day 14)
Title
Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)
Time Frame
Within 28 days after EOT (Day 5 or Day 7 or Day 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pte. Ltd. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pte Ltd
Official's Role
Study Director
Facility Information:
City
Hk
Country
Hong Kong
City
Bandung
Country
Indonesia
City
Jakarta
Country
Indonesia
City
Surabaya
Country
Indonesia
City
Ipoh
Country
Malaysia
City
Johor Bahru
Country
Malaysia
City
Kota Bharu
Country
Malaysia
City
Kuala Lumpur K Lumpur
Country
Malaysia
City
Kuala Lumpur N/A
Country
Malaysia
City
Pulau Pinang
Country
Malaysia
City
Selangor
Country
Malaysia
City
Seremban
Country
Malaysia
City
Terengganu
Country
Malaysia
City
Singapore
Country
Singapore
City
Hanoi
Country
Vietnam
City
Ho Chi Minh City
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
24636429
Citation
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.
Results Reference
derived

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

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