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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01201031
Other study ID # 98105
Secondary ID
Status Completed
Phase N/A
First received September 12, 2010
Last updated March 14, 2011
Start date April 2010
Est. completion date February 2011

Study information

Verified date March 2011
Source Taipei Medical University WanFang Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

Vancomycin -resistant enterococci(VRE) has emerged as one of the most common nosocomial pathogen of health-care associated infection since 1988. Although the new antimicrobial agents such as Tigecycline , Daptomycin, Linezolid have clinically effectiveness for the treatment of VRE, but there was not appropriate drugs for eradicating the colonization of VRE. So the active surveillance and strict contact precaution are the best methods for VRE colonization and transmission.

This is a one year study program, we select a unit as the study site. First month (January) is the prepare period. Therefore , we collect 3 months (from February to April) baseline data, then interrupted one month(May) for the health care worker's infection control education.

Then the intervention period are three months (from June to August), and the last four months(from September to December) are the analysis and evaluation period. In the baseline period, we only do the patient's active surveillance and environmental culture. In the intervention period, beside the patient's active surveillance and environmental culture, we add contact precaution as the infection control method. If patient has VRE infection, we prescribe appropriate antibiotic therapy until the culture result proved no growth of VRE.

The aim of this study is to compare and analyze these two period (baseline period and intervention period) for understanding the transmission, risk factors and carriage rate of VRE, as the important guidelines for the VRE infection control in the future.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date February 2011
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- all patients admitted to RCC unit

Exclusion Criteria:

- if the patients or family refused the exam of anal swab .

Study Design

Observational Model: Case-Only


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Taipei Medical University-WanFang Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

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