Condition category
Infections and Infestations
Date applied
05/09/2007
Date assigned
05/09/2007
Last edited
13/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephan Harbarth

ORCID ID

Contact details

Geneva University Hospitals
Infection Control Program
Geneva
CH-1211
Switzerland
+41 (0)22 372 3357
stephan.harbarth@hcuge.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To determine the effect of an early MRSA detection strategy on nosocomial MRSA infections in a cohort of surgical patients at a large teaching hospital.

Ethics approval

Ethics approval received from the local Institutional Review Board (Commission centrale d'éthique de la recherche aux HUG) on the 18th August 2004 (ref: JSL/cg, 126-2004).

Study design

A prospective, interventional cohort study using a cross-over design

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

MRSA (Methicillin-resistant Staphylococcus aureus)

Intervention

We carried out a prospective, interventional cohort study using a cross-over design to compare the effect of two different MRSA control strategies (rapid MRSA screening plus standard control versus standard infection control only) on the acquisition of nosocomial MRSA infection.

The study was conducted in the surgical department of the University of Geneva Hospitals (365 beds and 13,280 admissions in 2004). Twelve wards (including abdominal surgery, orthopedics, urology, neurosurgery, cardiovascular surgery, thoracic surgery, plastic surgery and solid organ transplant) were enrolled in the study. The study population included all adult patients admitted to the surgical department for greater than 24 hours. Patients admitted for ambulatory surgery were excluded as they were considered to be at low risk of MRSA infection.

Each ward was assigned to 1 of the 2 study groups and enrolled according to a pre-specified agenda encompassing 4 study phases. Phase I (July to September 2004) comprised a baseline surveillance period without MRSA on-admission screening. Phase II (October 2004 to June 2005) consisted of a 9-month intervention period with application of the rapid screening tool in neurosurgery, orthopedics, plastic surgery, cardiovascular and thoracic surgery, whereas the remaining wards served as control units. Follow-up of MRSA infections was continued in all wards throughout the next 2 months (phase III, washout period). In September 2005, the wards were switched for a further 9 months (crossover phase) to balance the effect of possible ward-related confounding variables. In phase IV (September 2005 to May 2006), rapid MRSA screening was applied to patients in urology, transplant and abdominal surgery. Follow-up of those patients who were operated before May 31, 2006 was terminated by September 2006.

The main study intervention consisted of the introduction of a molecular technique to enable early detection of MRSA carriage by rapid screening of admitted patients (including both elective and emergency admissions) in the intervention units. Standard infection control measures applied to MRSA patients in all units comprised the following elements: 1. Contact isolation of identified MRSA carriers in flagged side or single rooms, whenever available, with dedicated material (gowns, gloves, masks)
2. Topical decolonisation (nasal mupirocin ointment and chlorhexidine body washing) of known MRSA carriers for 5 days
3. Guidelines to adapt perioperative prophylaxis of MRSA carriers
4. A computerised MRSA alert system

No preemptive isolation was installed for patients without history of MRSA carriage. During the study, no antibiotic stewardship program was implemented.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Number of patients with nosocomial MRSA infection acquired in surgery, expressed as incidence per 1000 patient-days.

Secondary outcome measures

1. Nosocomial MRSA acquisition rate (expressed as the rate of new MRSA cases detected by any type of clinical isolate in previously MRSA-free patients per 1000 patient-days)
2. The rate of surgical site infections (per 100 procedures) and other site-specific infections caused by MRSA

Overall trial start date

01/07/2004

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All patients admitted to the surgical department for greater than 24 hours

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20000

Participant exclusion criteria

Ambulatory surgery

Recruitment start date

01/07/2004

Recruitment end date

30/09/2006

Locations

Countries of recruitment

Switzerland

Trial participating centre

Geneva University Hospitals
Geneva
CH-1211
Switzerland

Sponsor information

Organisation

The Geneva University Hospitals (Hopitaux Universitaires de Geneve [HUG]) (Switzerland)

Sponsor details

Infection Control Unit (Service Prevention Controle Infection [SPCI])
24 rue Micheli-du-Crest
Geneva-14
CH-1211
Switzerland

Sponsor type

Hospital/treatment centre

Website

http://www.hug-ge.ch/

Funders

Funder type

Research organisation

Funder name

Swiss National Science Foundation (Switzerland)

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Funder name

The Geneva University Hospitals (Hopitaux universitaires de Geneve [HUG]) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18334690

Publication citations

  1. Results

    Harbarth S, Fankhauser C, Schrenzel J, Christenson J, Gervaz P, Bandiera-Clerc C, Renzi G, Vernaz N, Sax H, Pittet D, Universal screening for methicillin-resistant Staphylococcus aureus at hospital admission and nosocomial infection in surgical patients., JAMA, 2008, 299, 10, 1149-1157, doi: 10.1001/jama.299.10.1149.

Additional files

Editorial Notes