Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00929643
First received: June 26, 2009
Last updated: August 6, 2012
Last verified: August 2012
Results First Received: June 27, 2012  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Complicated Intra-Abdominal Infection
Intervention: Other: no intervention

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Observational, epidemiological, noninterventional study.

Reporting Groups
  Description
All Enrolled Participants Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.

Participant Flow:   Overall Study
    All Enrolled Participants  
STARTED     203  
COMPLETED     201  
NOT COMPLETED     2  
Protocol Violation                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Enrolled Participants Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.

Baseline Measures
    All Enrolled Participants  
Number of Participants  
[units: participants]
  201  
Age  
[units: Years]
Mean ± Standard Deviation
  57.4  ± 19.7  
Gender  
[units: Participants]
 
Female     65  
Male     136  



  Outcome Measures
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1.  Primary:   Duration of Hospitalization   [ Time Frame: Baseline up to 6 months ]

2.  Primary:   Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)   [ Time Frame: Baseline up to 6 months ]

3.  Primary:   Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy   [ Time Frame: Baseline up to 6 months ]

4.  Primary:   Duration of Hospitalization (by Failure of Initial Empiric Treatment)   [ Time Frame: Baseline up to 6 months ]

5.  Secondary:   Percentage of Participants With Specific Pathogen   [ Time Frame: Baseline up to 6 months ]

6.  Secondary:   Percentage of Participants by Diagnosis at Discharge   [ Time Frame: Month 6 or study exit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00929643     History of Changes
Other Study ID Numbers: 3074A1-102311, B1811060
Study First Received: June 26, 2009
Results First Received: June 27, 2012
Last Updated: August 6, 2012
Health Authority: Greece: National Organization of Medicines