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

Free University of Brussels (ULB)

Status: Completed

Conditions: Staphylococcal Infection; Methicillin Resistance; Staphylococcus Aureus

Treatments: Other: Rapid MRSA PCR test for screening carriers

Study type: Interventional

Funder types: Other

Identifiers

NCT00846105

Erasme-ULB-P2008/201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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7,400 participants in 2 patient groups

Rapid PCR screen

Experimental group

Description:

Rapid PCR screen test for detection of MRSA carriers upon hospital admission

Treatment:

Other: Rapid MRSA PCR test for screening carriers

Conventional culture

Active Comparator group

Description:

Conventional culture screen for detection of MRSA carriers upon hospital admission

Treatment:

Other: Rapid MRSA PCR test for screening carriers