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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00685867
Other study ID # LSHP-CT-037940
Secondary ID LSHP-CT-037940
Status Completed
Phase N/A
First received May 27, 2008
Last updated August 20, 2012
Start date May 2008
Est. completion date December 2010

Study information

Verified date August 2012
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

The study is a two-arm controlled multi-centre trial of two strategies to reduce nosocomial MRSA transmission and infection among surgical patients. Enrolment and primary analyses will be performed at the hospital level. A total of ten adult surgical departments with at least 3 surgical subspecialties each will participate in the study. Sites of the study are located in 9 countries (UK, France, Spain, Germany, Switzerland, Italy, Serbia, Greece and Israel).

The primary objective is to determine the effect of an early MRSA detection & decolonization & isolation strategy compared to an enhanced standard control strategy on healthcare-associated MRSA isolation rates among surgical patients at risk of MRSA carriage, who are hospitalized for at least 24 hours.


Recruitment information / eligibility

Status Completed
Enrollment 126750
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Surgical patients with LOS>24h

Exclusion Criteria:

- Surgical patients with LOS<24h

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Rapid molecular MRSA test
PCR-based rapid screening for MRSA carriage
Behavioral:
Hand hygiene promotion
Promotion and monitoring of hand hygiene, with special emphasis on alcohol-based hand rubs and feedback of hand hygiene compliance Standard precautions (e.g. use of gloves for contacts with wounds and body fluids) Isolation precautions according to the hospitals' capacity and strategy Additional basic infection control interventions (if necessary)

Locations

Country Name City State
Switzerland Geneva University Hospitals Geneva

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Geneva European Commission

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nosocomial MRSA isolation rate (expressed as the monthly rate of MRSA in clinical isolates divided by the number of susceptible patients per hundred) Monthly No
Secondary Nosocomial MRSA infection rate (= number of nosocomial MRSA infections per 100 admissions) Monthly No
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Completed NCT01814371 - Individualized vs. Household MRSA Decolonization N/A