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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:
ClinicalTrials.gov Identifier:
NCT00167986
First Posted: September 14, 2005
Last Update Posted: March 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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:


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

Estimated Enrollment: 480
Study Start Date: January 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00167986     History of Changes
Other Study ID Numbers: 101498
First Submitted: September 11, 2005
First Posted: September 14, 2005
Last Update Posted: March 15, 2007
Last Verified: March 2007

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

Additional relevant MeSH terms:
Klebsiella Infections
Infection
Communicable Diseases
Pneumonia
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