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...
Date First Received: September 11, 2005
Last Updated: March 14, 2007
Verified by: Wyeth, March 2007
Clinical Trial Phase: Phase 4 | Start Date: January 2005
Overall Status: Completed
Estimated Enrollment: 1500
Brief Summary
Official Title: “Effects on the Emergence and Transmission of Vancomycin-Resistant Enterococci After Changes in Antibiotic Use in a Hematology Unit.”
Condition Keyword(s):
Intervention(s):
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 Type: Observational
Study Design: Natural History, Longitudinal, Case Control, Prospective Study
Intervention(s) in this Clinical Trial
- Drug: Piperacillin/tazobactam and other β-lactam/β-lactamase
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00167960
Study ID Number: 0910X-101525
ClinicalTrials.gov Identifier: NCT00167960
Health Authority: Korea: Food and Drug Administration
Clinical Trials Authorship and Review
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