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Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00167960
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 the impact of the restriction of the third and forth generation cephalosporins on the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a surgical intensive care unit (SICU)

Condition Intervention Phase
Gram-Positive Bacterial Infections Drug: Piperacillin/tazobactam and other β-lactam/β-lactamase Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Effects on the Emergence and Transmission of Vancomycin-Resistant Enterococci After Changes in Antibiotic Use in a Hematology Unit.

Resource links provided by NLM:


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

Estimated Enrollment: 1500
Study Start Date: January 2005
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 SICU.
  • Eligible patients will be patients of either sex, 18 years of age or older who are admitted or transferred to the SICU.
  • Provide written informed consent

Exclusion Criteria:

  • Patients who have hypersensitivity to penicillin, cephalosporins or beta-lactamase inhibitors.
  • Females who are pregnant and breast feeding
  • Any underlying conditions or non-infectious diseases that will be ultimately fatal within 48 hours.
  • Those who have already been participating other clinical study related with antibiotics.
  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): NCT00167960


Locations
Korea, Republic of
Incheon, Korea, Republic of, 405-760
Ulsan, Korea, Republic of, 682-714
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: NCT00167960     History of Changes
Other Study ID Numbers: 0910X-101525
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:
Bacterial Infections
Gram-Positive Bacterial Infections
Vancomycin
Tazobactam
Piperacillin
Piperacillin, tazobactam drug combination
Penicillanic Acid
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action