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).
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Brugge, Bélgica, B-8000
- Algemeen Ziekenhuis Sint-Jan AV
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Brussels, Bélgica, B-1070
- ULB Hôpital Erasme
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Rapid PCR screen
Rapid PCR screen test for detection of MRSA carriers upon hospital admission
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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.
Otros nombres:
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Comparador activo: Conventional culture
Conventional culture screen for detection of MRSA carriers upon hospital admission
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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
Periodo de tiempo: 5-10 months
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5-10 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Median time required for detection of MRSA carriage after admission
Periodo de tiempo: 5-10 months
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5-10 months
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Median time required for starting isolation of MRSA carriers
Periodo de tiempo: 5-10 months
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5-10 months
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Number of patient-days of MRSA carrier stay in non-isolated conditions
Periodo de tiempo: 5-10 months
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5-10 months
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MRSA nosocomial infection rate
Periodo de tiempo: 5-10 months
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5-10 months
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MRSA cross-transmission rate
Periodo de tiempo: 5-10 months
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5-10 months
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Sensitivity and specificity of PCR vs conventional MRSA screening by culture
Periodo de tiempo: 10 months
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10 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marc J Struelens, MD, PhD, Erasme University Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Erasme-ULB-P2008/201
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