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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00167986
First received: September 11, 2005
Last updated: March 14, 2007
Last verified: March 2007
History of Changes
  Purpose

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).


Condition Intervention Phase
Escherichia Coli Infections
Klebsiella Infections
 Drug: vancomycin-resistant enterococci and ESBL
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Estimated Enrollment: 480
Study Start Date: January 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167986

Locations
Korea, Republic of
Gyunggi-do, Korea, Republic of, 431-070
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00167986     History of Changes
Other Study ID Numbers: 101498
Study First Received: September 11, 2005
Last Updated: March 14, 2007
Health Authority: Korea: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Bacterial Infections

Additional relevant MeSH terms:
Pneumonia
Klebsiella Infections
Escherichia coli Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Enterobacteriaceae Infections
 Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Vancomycin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013