NCT00685867

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126,750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

Typical duration for not_applicable

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

May 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 21, 2012

Status Verified

August 1, 2012

Enrollment Period

2.6 years

First QC Date

May 27, 2008

Last Update Submit

August 20, 2012

Conditions

Keywords

Staphylococcus aureusResistancePrevention

Outcome Measures

Primary Outcomes (1)

  • Nosocomial MRSA isolation rate (expressed as the monthly rate of MRSA in clinical isolates divided by the number of susceptible patients per hundred)

    Monthly

Secondary Outcomes (1)

  • Nosocomial MRSA infection rate (= number of nosocomial MRSA infections per 100 admissions)

    Monthly

Study Arms (2)

1

EXPERIMENTAL

Rapid detection

Other: Rapid molecular MRSA test

2

OTHER

Enhanced infection control

Behavioral: Hand hygiene promotion

Interventions

PCR-based rapid screening for MRSA carriage

1

* 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)

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Surgical patients with LOS\>24h

You may not qualify if:

  • Surgical patients with LOS\<24h

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

Location

Related Publications (1)

  • Lee AS, Cooper BS, Malhotra-Kumar S, Chalfine A, Daikos GL, Fankhauser C, Carevic B, Lemmen S, Martinez JA, Masuet-Aumatell C, Pan A, Phillips G, Rubinovitch B, Goossens H, Brun-Buisson C, Harbarth S; MOSAR WP4 Study Group. Comparison of strategies to reduce meticillin-resistant Staphylococcus aureus rates in surgical patients: a controlled multicentre intervention trial. BMJ Open. 2013 Sep 19;3(9):e003126. doi: 10.1136/bmjopen-2013-003126.

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 29, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 21, 2012

Record last verified: 2012-08

Locations