Efficacy Study of Rapid Test to Prevent Hospital Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA)
Primary Purpose
Methicillin Resistance, Staphylococcus Aureus, Staphylococcal Infection
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Rapid MRSA PCR test for screening carriers
Sponsored by
About this trial
This is an interventional prevention trial for Methicillin Resistance focused on measuring methicillin resistant Staphylococcus aureus, MRSA, cross-infection, staphylococcal infection, infection control
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
Sites / Locations
- Algemeen Ziekenhuis Sint-Jan AV
- ULB Hopital Erasme
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rapid PCR screen
Conventional culture
Arm Description
Rapid PCR screen test for detection of MRSA carriers upon hospital admission
Conventional culture screen for detection of MRSA carriers upon hospital admission
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Median time required for detection of MRSA carriage after admission
Median time required for starting isolation of MRSA carriers
Number of patient-days of MRSA carrier stay in non-isolated conditions
MRSA nosocomial infection rate
MRSA cross-transmission rate
Sensitivity and specificity of PCR vs conventional MRSA screening by culture
Full Information
NCT ID
NCT00846105
First Posted
February 17, 2009
Last Updated
June 14, 2010
Sponsor
Erasme University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00846105
Brief Title
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
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Erasme University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methicillin Resistance, Staphylococcus Aureus, Staphylococcal Infection
Keywords
methicillin resistant Staphylococcus aureus, MRSA, cross-infection, staphylococcal infection, infection control
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
7400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rapid PCR screen
Arm Type
Experimental
Arm Description
Rapid PCR screen test for detection of MRSA carriers upon hospital admission
Arm Title
Conventional culture
Arm Type
Active Comparator
Arm Description
Conventional culture screen for detection of MRSA carriers upon hospital admission
Intervention Type
Other
Intervention Name(s)
Rapid MRSA PCR test for screening carriers
Other Intervention Name(s)
GeneXpert MRSA, Cepheid., Real-time PCR assay for MRSA
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Time Frame
5-10 months
Secondary Outcome Measure Information:
Title
Median time required for detection of MRSA carriage after admission
Time Frame
5-10 months
Title
Median time required for starting isolation of MRSA carriers
Time Frame
5-10 months
Title
Number of patient-days of MRSA carrier stay in non-isolated conditions
Time Frame
5-10 months
Title
MRSA nosocomial infection rate
Time Frame
5-10 months
Title
MRSA cross-transmission rate
Time Frame
5-10 months
Title
Sensitivity and specificity of PCR vs conventional MRSA screening by culture
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc J Struelens, MD, PhD
Organizational Affiliation
Erasme University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algemeen Ziekenhuis Sint-Jan AV
City
Brugge
ZIP/Postal Code
B-8000
Country
Belgium
Facility Name
ULB Hopital Erasme
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
16563177
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.
Results Reference
background
PubMed Identifier
24836438
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.
Results Reference
derived
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Efficacy Study of Rapid Test to Prevent Hospital Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA)
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