- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00167986
Study Evaluating Antibiotic Use in Reducing Vancomycin-Resistant Enterococci and ESBL Producing Escherichia Coli and Klebsiella Pneumoniae in Intensive Care
March 14, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
Antibiotic Intervention Trial in a Medical Intensive Care Unit to Reduce the Acquisition of Vancomycin-Resistant Enterococci and ESBL Producing Escherichia Coli and Klebsiella Pneumoniae.
To determine whether the restriction of 3rd generation cephalosporins and carbapenems contribute to the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a medical intensive care unit (MICU).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment
480
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gyunggi-do, Korea, Republic of, 431-070
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients admitted to or transferred to the MICU.
- Patients 18 years of age or older.
- Provide written informed consent.
Exclusion Criteria:
- Patients known to be infected or colonized by VRE or ESBL-producing E.coli, K.pneumoniae.
- Patients who have hypersensitivity to penicillin.
- Any underlying conditions or diseases that will be ultimately fatal within 48 hours.
- Any concurrent condition or medication which would interfere with absorption or metabolism of study drugs.
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
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
January 1, 2005
Study Registration Dates
First Submitted
September 11, 2005
First Submitted That Met QC Criteria
September 11, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
March 15, 2007
Last Update Submitted That Met QC Criteria
March 14, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Enterobacteriaceae Infections
- Infections
- Communicable Diseases
- Pneumonia
- Escherichia coli Infections
- Klebsiella Infections
- Anti-Infective Agents
- Anti-Bacterial Agents
- Vancomycin
Other Study ID Numbers
- 101498
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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