Official Title: “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 Type: Observational

Study Design: Natural History, Longitudinal, Case Control, Prospective Study

Intervention(s) in this Clinical Trial

• Drug: vancomycin-resistant enterococci and ESBL

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.

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

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00167986

Study ID Number: 101498

ClinicalTrials.gov Identifier: NCT00167986

Health Authority: Korea: Food and Drug Administration