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

Staphylococcus Aureus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846105
• Other study ID #: Erasme-ULB-P2008/201
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: June 14, 2010
• Start date: February 2009
• Est. completion date: May 2010

Study information

• Verified date: June 2010
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7400
• Est. completion date: May 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Methicillin Resistance
• Staphylococcal Infection
• Staphylococcal Infections
• Staphylococcus Aureus

Intervention

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.

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Sint-Jan AV	Brugge
Belgium	ULB Hopital Erasme	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Median time required for detection of MRSA carriage after admission		5-10 months	No
Secondary	Median time required for starting isolation of MRSA carriers		5-10 months	No
Secondary	Number of patient-days of MRSA carrier stay in non-isolated conditions		5-10 months	No
Secondary	MRSA nosocomial infection rate		5-10 months	No
Secondary	MRSA cross-transmission rate		5-10 months	No
Secondary	Sensitivity and specificity of PCR vs conventional MRSA screening by culture		10 months	No

External Links

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