Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit

This study has been completed.

First Received: September 11, 2005 Last Updated: March 14, 2007 History of Changes

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

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.

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections

Drug Information available for: Piperacillin sodium Piperacillin Tazobactam Vancomycin

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Wyeth:

Bacterial Infections

Study placed in the following topic categories:

Bacterial Infections
Anti-Infective Agents
Lactams
Anti-Bacterial Agents
Gram-Positive Bacterial Infections

Vancomycin
Tazobactam
Piperacillin
Piperacillin-tazobactam combination product

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Therapeutic Uses

Piperacillin
Piperacillin-tazobactam combination product
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2009