Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit - Full Text View

Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit

This study has been completed.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00167960

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 IV

MedlinePlus related topics:

Bacterial Infections

ChemIDplus related topics:

Vancomycin Vancomycin hydrochloride Piperacillin Piperacillin sodium Tazobactam

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Case Control, Prospective Study

Official Title:	Effects on the Emergence and Transmission of Vancomycin-Resistant Enterococci After Changes in Antibiotic Use in a Hematology Unit.

Further study details as provided by Wyeth:

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

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

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Study ID Numbers:	0910X-101525
First Received:	September 11, 2005
Last Updated:	March 14, 2007
ClinicalTrials.gov Identifier:	NCT00167960
Health Authority:	Korea: Food and Drug Administration