NCT01201031

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 16, 2011

Status Verified

March 1, 2011

Enrollment Period

5 months

First QC Date

September 12, 2010

Last Update Submit

March 14, 2011

Conditions

Keywords

for the active surveillance of VRE colinization and infection

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients admitted to RCC unit , and these patients received active surveillance of VRE colinization

You may qualify if:

  • all patients admitted to RCC unit

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University-WanFang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Wen-Sen Lee

    Taipei Medical University WanFang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2010

First Posted

September 14, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2010

Study Completion

February 1, 2011

Last Updated

March 16, 2011

Record last verified: 2011-03

Locations