Study Evaluating Vancomycin-Resistant Enterococci 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...

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):

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

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