- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01788449
Study Evaluating the Association of Antibiotic Measures and Control of Bacterial Resistance
February 12, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
Association of Antibiotic Measures and Control of Bacterial Resistance
Assess efficacy of piperacillin/tazobactam in reducing the cases of colonization and infection of bacteria.
Study Overview
Status
Completed
Conditions
Detailed Description
Primarily, this study is designed to assess the efficacy of piperacillin/tazobactam in reducing the cases of colonization and infection of extended-spectrum betalactamases (ESBLs) producing E.coli or K pneumoniae, S aureus methicillin resistant (MRSA) and Enterococcus vancomycin resistant (VRE).
Secondly, this study plans to determine the acquisition rate of ESBL producing E Coli or K pneumoniae, methicillin resistant S Aureus (MRSA) and vancomycin resistant Enterococcus spp (VRE), both pre- and post-intervention.
Study Type
Observational
Enrollment (Actual)
335
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Intensive Care Unit (ICU)
Description
All patients admitted in ICU will be enrolled (who qualify for treatment).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endpoints will be efficacy of piperacillin/tazobactam in reducing colonization rates and infection of E coli or K pneumoniae, vancomycin resistant enterococcus and methicillin resistant S aureus
Time Frame: 8 months
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endpoints will be acquisition and infection rate of ESBL producing E coli or K pneumoniae, vancomycin resistant enterococcus and methicillin resistant S aureus
Time Frame: 8 months
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
August 6, 2009
First Submitted That Met QC Criteria
February 7, 2013
First Posted (Estimate)
February 11, 2013
Study Record Updates
Last Update Posted (Estimate)
February 13, 2013
Last Update Submitted That Met QC Criteria
February 12, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0910X-101852
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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