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

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson (Hong Kong) Ltd.
Information provided by:
Johnson & Johnson Pte Ltd
ClinicalTrials.gov Identifier:
NCT00986102
First received: September 25, 2009
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Pneumonia
Pneumonia, Ventilator-Associated
Urinary Tract Infections
Drug: doripenem
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pte Ltd:

Primary Outcome Measures:
  • Number of Participants With the Usage of Doripenem as Per the Approved Indication [ Time Frame: 5 to 14 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 to 14 days ] [ Designated as safety issue: No ]
  • Duration of Antibiotic Therapy [ Time Frame: 5 to 14 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Day -1) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Day 5 or Day 7 or Day 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Medical Resource Utilization [ Time Frame: From Baseline (Day -1) upto the duration of hospital stay of a participant ] [ Designated as safety issue: No ]
    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) [ Time Frame: Within 28 days after EOT (Day 5 or Day 7 or Day 14) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 216
Study Start Date: July 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986102

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
Sponsors and Collaborators
Johnson & Johnson Pte Ltd
Johnson & Johnson (Hong Kong) Ltd.
Investigators
Study Director: Johnson & Johnson Pte. Ltd. Clinical Trial Johnson & Johnson Pte Ltd
  More Information

No publications provided by Johnson & Johnson Pte Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Physician, Anti-Infectives, Johnson & Johnson (Philippines) Inc., Philippines
ClinicalTrials.gov Identifier: NCT00986102     History of Changes
Other Study ID Numbers: CR016321, DORIBAC4007
Study First Received: September 25, 2009
Results First Received: January 4, 2013
Last Updated: January 4, 2013
Health Authority: Singapore: Health Sciences Authority
Vietnam: Ministry of Health

Keywords provided by Johnson & Johnson Pte Ltd:
Carbapenem
Doripenem
Doribax
Nosocomial pneumonia, Intra-abdominal infections
Urinary tract infection

Additional relevant MeSH terms:
Pneumonia
Urinary Tract Infections
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Urologic Diseases
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on August 25, 2014