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Efficacy Study of Rapid Test to Prevent Hospital Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA)

Not Applicable
Completed
Conditions
Methicillin Resistance
Staphylococcus Aureus
Staphylococcal Infection
Interventions
Other: Rapid MRSA PCR test for screening carriers
Registration Number
NCT00846105
Lead Sponsor
Erasme University Hospital
Brief Summary

The purpose of this study is to evaluate the efficacy of a novel PCR-based laboratory test for rapid detection of MRSA carriers to prevent transmission of MRSA in the Belgian acute care hospital setting.

Detailed Description

Methicillin-resistant Staphylococcus aureus (MRSA) strains have become endemic pathogens in acute and chronic healthcare facilities in Belgium. MRSA infection is causing increased public concern as it carries a significant risk of morbidity, mortality and has been linked to substantial excess healthcare costs.

Efficient control of MRSA transmission within healthcare facilities critically depends on screening for and isolation of MRSA carriers among admitted patients. Active surveillance cultures for MRSA are now part of clinical practice recommendations both in Europe and the USA. Indeed, studies have indicated that up to 70 % of the patient reservoir for MRSA among hospitalized patients can only be detected by active sampling of muco-cutaneous colonization sites. There is an urgent public health need for early and reliable detection of carriers of MRSA among patients admitted to healthcare facilities, to inform patient isolation and decontamination procedures, and thereby more effectively control cross-infection

The general objectives of this intervention study to be conducted in two large Belgian hospitals are to measure the impact of rapid (\< 3 h) PCR detection of MRSA carriage upon patient admission on shortening the delay to implement contact isolation precautions for carriers and reducing nosocomial MRSA transmission to patients admitted in the same wards.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
7400
Inclusion Criteria
  • All patients admitted for more than 48h to a ward in which evaluation in the previous baseline period met the following:

    • > 80 % compliance with admission and discharge conventional culture screening, for the pooled admissions to all study wards;
    • > 80 % compliance with additional MRSA contact isolation procedures, based on a sample of 50 patient care contact observations per hospital in all study wards;
    • pooled incidence of nosocomial MRSA acquisition ≥ 1.5 new cases /100 at risk admissions in the study wards.
Exclusion Criteria
  • Patients staying 48h or less in the study wards

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Rapid PCR screenRapid MRSA PCR test for screening carriersRapid PCR screen test for detection of MRSA carriers upon hospital admission
Conventional cultureRapid MRSA PCR test for screening carriersConventional culture screen for detection of MRSA carriers upon hospital admission
Primary Outcome Measures
NameTimeMethod
To determine if a ≥ 50 % reduction of incidence of nosocomial MRSA acquisition can be observed after replacing culture by PCR for universal MRSA screening of patients upon admission to high incidence units in two acute care hospitals5-10 months
Secondary Outcome Measures
NameTimeMethod
Median time required for detection of MRSA carriage after admission5-10 months
Median time required for starting isolation of MRSA carriers5-10 months
Number of patient-days of MRSA carrier stay in non-isolated conditions5-10 months
MRSA nosocomial infection rate5-10 months
MRSA cross-transmission rate5-10 months
Sensitivity and specificity of PCR vs conventional MRSA screening by culture10 months

Trial Locations

Locations (2)

ULB Hopital Erasme

🇧🇪

Brussels, Belgium

Algemeen Ziekenhuis Sint-Jan AV

🇧🇪

Brugge, Belgium

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