- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00167960
Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit
March 14, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
Effects on the Emergence and Transmission of Vancomycin-Resistant Enterococci After Changes in Antibiotic Use in a Hematology Unit.
To determine the impact of the restriction of the third and forth generation cephalosporins on the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a surgical intensive care unit (SICU)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment
1500
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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Incheon, Korea, Republic of, 405-760
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Ulsan, Korea, Republic of, 682-714
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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 SICU.
- Eligible patients will be patients of either sex, 18 years of age or older who are admitted or transferred to the SICU.
- Provide written informed consent
Exclusion Criteria:
- Patients who have hypersensitivity to penicillin, cephalosporins or beta-lactamase inhibitors.
- Females who are pregnant and breast feeding
- Any underlying conditions or non-infectious diseases that will be ultimately fatal within 48 hours.
- Those who have already been participating other clinical study related with antibiotics.
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
- Infections
- Bacterial Infections and Mycoses
- Bacterial Infections
- Gram-Positive Bacterial Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- beta-Lactamase Inhibitors
- Piperacillin
- Tazobactam
- Piperacillin, Tazobactam Drug Combination
- Lactams
- beta-Lactams
Other Study ID Numbers
- 0910X-101525
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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