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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Two-Center Intervention Study to Evaluate the Impact of Rapid Molecular Screening on Nosocomial Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA).

Conditions
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Methicillin Resistance, Staphylococcus Aureus, Staphylococcal Infection

Intervention / Treatment
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* Other: Rapid MRSA PCR test for screening carriers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid PCR screen<br>Rapid PCR screen test for detection of MRSA carriers upon hospital admission | Other: Rapid MRSA PCR test for screening carriers<br>* In the rapid test intervention arm, all patients admitted to study wards will be sampled within 24 h after admission. To ensure comparison of like with like, sample taking will include: (1) a swab from the anterior nares for PCR testing according to the test manufacturer's instructions; (2) the swab of anterior nares, and swabs from throat, perineum and of any wounds, bladder catheter or intravenous catheter exit site will be processed by conventional testing.<br>* Other names: Real-time PCR assay for MRSA;|
| Active Comparator: Conventional culture<br>Conventional culture screen for detection of MRSA carriers upon hospital admission | Other: Rapid MRSA PCR test for screening carriers<br>* In the rapid test intervention arm, all patients admitted to study wards will be sampled within 24 h after admission. To ensure comparison of like with like, sample taking will include: (1) a swab from the anterior nares for PCR testing according to the test manufacturer's instructions; (2) the swab of anterior nares, and swabs from throat, perineum and of any wounds, bladder catheter or intravenous catheter exit site will be processed by conventional testing.<br>* Other names: Real-time PCR assay for MRSA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 hospitals |  | 5-10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time required for detection of MRSA carriage after admission |  | 5-10 months | 
| Median time required for starting isolation of MRSA carriers |  | 5-10 months | 
| Number of patient-days of MRSA carrier stay in non-isolated conditions |  | 5-10 months | 
| MRSA nosocomial infection rate |  | 5-10 months | 
| MRSA cross-transmission rate |  | 5-10 months | 
| Sensitivity and specificity of PCR vs conventional MRSA screening by culture |  | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methicillin resistant Staphylococcus aureus, MRSA, cross-infection, staphylococcal infection, infection control