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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
History of Changes
Results First Received: January 4, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pneumonia
Pneumonia, Ventilator-Associated
Urinary Tract Infections
Intervention: Drug: doripenem

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
217 patients were enrolled at sites in Malaysia, Indonesia, Singapore, Vietnam and Hong Kong.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
217 patients were enrolled and 216 received study medication. 1 patient was enrolled but subsequently withdrew consent before receiving the study medication. 61 patients discontinued study medication prior to end of treatment.

Reporting Groups
  Description
Nosocomial Pneumonia (NP) 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
Ventilator-Associated Pneumonia (VAP) 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
Complicated Urinary Tract Infection (cUTI) 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
Complicated Intra-abdominal Infection (cIAI) 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days

Participant Flow:   Overall Study
    Nosocomial Pneumonia (NP)     Ventilator-Associated Pneumonia (VAP)     Complicated Urinary Tract Infection (cUTI)     Complicated Intra-abdominal Infection (cIAI)  
STARTED     53 [1]   77 [1]   19 [1]   67 [1]
COMPLETED     52     75     19     66  
NOT COMPLETED     1     2     0     1  
Lost to Follow-up                 0                 1                 0                 1  
Withdrawal by Subject                 1                 1                 0                 0  
[1] Number of participants who received study medication



  Baseline Characteristics
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Reporting Groups
  Description
Nosocomial Pneumonia (NP) 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
Ventilator-Associated Pneumonia (VAP) 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
Complicated Urinary Tract Infection (cUTI) 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
Complicated Intra-abdominal Infection (cIAI) 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
Total Total of all reporting groups

Baseline Measures
    Nosocomial Pneumonia (NP)     Ventilator-Associated Pneumonia (VAP)     Complicated Urinary Tract Infection (cUTI)     Complicated Intra-abdominal Infection (cIAI)     Total  
Number of Participants  
[units: participants]
 		  53     77     19     67     216  
Age  
[units: years]
Mean ± Standard Deviation 		  54.1  ± 17.52     44.4  ± 19.17     58.2  ± 13.23     49.2  ± 16.13     49.5  ± 17.88  
Gender  
[units: Participants]
 		         
Female     16     19     13     24     72  
Male     37     58     6     43     144  
Race/Ethnicity, Customized  
[units: Participants]
 		         
Chinese     8     13     7     28     56  
Malay     33     44     8     35     120  
Indian     2     3     2     0     7  
Aboriginal     0     0     0     1     1  
White     0     1     0     1     2  
Others     10     16     2     2     30  
Patient's location in the hospital upon enrollment  
[units: Participants]
 		         
Intensive Care Unit (ICU)     30     69     9     29     137  
Non –ICU     23     8     10     36     77  
Missing     0     0     0     2     2  



  Outcome Measures
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1.  Primary:   Number of Participants With the Usage of Doripenem as Per the Approved Indication   [ Time Frame: 5 to 14 days ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Different Mode of Usage of Doripenem   [ Time Frame: 5 to 14 days ]
  Show Outcome Measure 2

3.  Primary:   Duration of Antibiotic Therapy   [ Time Frame: 5 to 14 days ]
  Show Outcome Measure 3

4.  Primary:   Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score   [ Time Frame: Baseline (Day -1) ]
  Show Outcome Measure 4

5.  Secondary:   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 ]
  Show Outcome Measure 5

6.  Secondary:   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 ]
  Show Outcome Measure 6

7.  Secondary:   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 ]
  Show Outcome Measure 7

8.  Secondary:   Medical Resource Utilization   [ Time Frame: From Baseline (Day -1) upto the duration of hospital stay of a participant ]
  Show Outcome Measure 8

9.  Secondary:   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) ]
  Show Outcome Measure 9

10.  Secondary:   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) ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: VP MEDICAL AFFAIRS ASIA PACIFIC
Organization: Jan-Cil Singapore
phone: +65 6827 6753


No publications provided


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