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).
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Brugge, Belgia, B-8000
- Algemeen Ziekenhuis Sint-Jan AV
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Brussels, Belgia, B-1070
- ULB Hôpital Erasme
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
Andre navn:
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Aktiv komparator: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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
Tidsramme: 5-10 months
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5-10 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Median time required for detection of MRSA carriage after admission
Tidsramme: 5-10 months
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5-10 months
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Median time required for starting isolation of MRSA carriers
Tidsramme: 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
Tidsramme: 5-10 months
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5-10 months
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MRSA nosocomial infection rate
Tidsramme: 5-10 months
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5-10 months
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MRSA cross-transmission rate
Tidsramme: 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
Tidsramme: 10 months
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10 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Marc J Struelens, MD, PhD, Erasme University Hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Erasme-ULB-P2008/201
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