Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00167960
First received: September 11, 2005
Last updated: March 14, 2007
Last verified: March 2007
  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
Time Perspective: Longitudinal
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

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 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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00167960     History of Changes
Other Study ID Numbers: 0910X-101525
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:
Bacterial Infections
Gram-Positive Bacterial Infections
Piperacillin
Vancomycin
Piperacillin-tazobactam combination product
Penicillanic Acid
Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014