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NCT00167986 Clinical Trial

Study Evaluating Antibiotic Use in Reducing Vancomycin-Resistant Enterococci and ESBL Producing Escherichia Coli and Klebsiella Pneumoniae in Intensive Care

Escherichia Coli Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00167986
Other study ID # 101498
Secondary ID
Status Completed
Phase Phase 4
First received September 11, 2005
Last updated March 14, 2007
Start date January 2005

Study information
Verified date March 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 480
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Drug:
• vancomycin-resistant enterococci and ESBL

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

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