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

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

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.

Study Overview

• Status: Completed
• Conditions: Staphylococcus Aureus; Staphylococcal Infection; Methicillin Resistance
• Intervention / Treatment: Other: Rapid MRSA PCR test for screening carriers

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.

• Study Type: Interventional
• Enrollment (Anticipated): 7400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, B-8000
    • Algemeen Ziekenhuis Sint-Jan AV
  • Brussels, Belgium, B-1070
    • ULB Hôpital Erasme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapid PCR screen; Rapid PCR screen test for detection of MRSA carriers upon hospital admission	Other: Rapid MRSA PCR test for screening carriers; 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.; Other Names: GeneXpert MRSA, Cepheid.; Real-time PCR assay for MRSA
Active Comparator: Conventional culture; Conventional culture screen for detection of MRSA carriers upon hospital admission	Other: Rapid MRSA PCR test for screening carriers; 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.; Other Names: GeneXpert MRSA, Cepheid.; Real-time PCR assay for MRSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Marc J Struelens, MD, PhD, Erasme University Hospital

Publications and helpful links

General Publications

• Struelens MJ, Denis O. Rapid molecular detection of methicillin-resistant Staphylococcus aureus: a cost-effective tool for infection control in critical care? Crit Care. 2006;10(2):128. doi: 10.1186/cc4855.
• Roisin S, Laurent C, Denis O, Dramaix M, Nonhoff C, Hallin M, Byl B, Struelens MJ. Impact of rapid molecular screening at hospital admission on nosocomial transmission of methicillin-resistant Staphylococcus aureus: cluster randomised trial. PLoS One. 2014 May 16;9(5):e96310. doi: 10.1371/journal.pone.0096310. eCollection 2014.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: February 17, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (Estimate): February 18, 2009

Study Record Updates

• Last Update Posted (Estimate): June 15, 2010
• Last Update Submitted That Met QC Criteria: June 14, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: MRSA; staphylococcal infection; infection control; methicillin resistant Staphylococcus aureus; cross-infection
• Additional Relevant MeSH Terms: Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Staphylococcal Infections
• Other Study ID Numbers: Erasme-ULB-P2008/201