Clinical trial NCT00846105: Efficacy Study of Rapid Test to Prevent Hospital Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA)
Official title: Two-Center Intervention Study to Evaluate the Impact of Rapid Molecular Screening on Nosocomial Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methicillin Resistance
Staphylococcus Aureus
Staphylococcal Infection
Keywords: methicillin resistant Staphylococcus aureus
MRSA
cross-infection
staphylococcal infection
infection control
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 7400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 5-10 months
Secondary outcomes:
measure: Median time required for detection of MRSA carriage after admission
timeFrame: 5-10 months
measure: Median time required for starting isolation of MRSA carriers
timeFrame: 5-10 months
measure: Number of patient-days of MRSA carrier stay in non-isolated conditions
timeFrame: 5-10 months
measure: MRSA nosocomial infection rate
timeFrame: 5-10 months
measure: MRSA cross-transmission rate
timeFrame: 5-10 months
measure: Sensitivity and specificity of PCR vs conventional MRSA screening by culture
timeFrame: 10 months
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint-Jan AV
city: Brussels
country: Belgium
facility: ULB Hopital Erasme
Study officials:
affiliation: Erasme University Hospital
name: Marc J Struelens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.