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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
  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
Time Perspective: Longitudinal
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Communicable Diseases
Escherichia coli Infections
Infection
Klebsiella Infections
Pneumonia
Bacterial Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014