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NCT00167960 Clinical Trial

Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit

Gram-Positive Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00167960
Other study ID # 0910X-101525
Secondary ID
Status Completed
Phase Phase 4
First received September 11, 2005
Last updated March 14, 2007
Start date January 2005

Study information
Verified date March 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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)

Recruitment information / eligibility
Status Completed
Enrollment 1500
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Drug:
• Piperacillin/tazobactam and other ß-lactam/ß-lactamase

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

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