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

This study has been completed.
Sponsor:
Information provided by:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT00846105
First received: February 17, 2009
Last updated: June 14, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Methicillin Resistance
Staphylococcus Aureus
Staphylococcal Infection
Other: Rapid MRSA PCR test for screening carriers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Two-Center Intervention Study to Evaluate the Impact of Rapid Molecular Screening on Nosocomial Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA).

Resource links provided by NLM:


Further study details as provided by Erasme University Hospital:

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 [ Time Frame: 5-10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median time required for detection of MRSA carriage after admission [ Time Frame: 5-10 months ] [ Designated as safety issue: No ]
  • Median time required for starting isolation of MRSA carriers [ Time Frame: 5-10 months ] [ Designated as safety issue: No ]
  • Number of patient-days of MRSA carrier stay in non-isolated conditions [ Time Frame: 5-10 months ] [ Designated as safety issue: No ]
  • MRSA nosocomial infection rate [ Time Frame: 5-10 months ] [ Designated as safety issue: No ]
  • MRSA cross-transmission rate [ Time Frame: 5-10 months ] [ Designated as safety issue: No ]
  • Sensitivity and specificity of PCR vs conventional MRSA screening by culture [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 7400
Study Start Date: February 2009
Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rapid PCR screen
Rapid PCR screen test for detection of MRSA carriers upon hospital admission
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.
Other Names:
  • GeneXpert MRSA, Cepheid.
  • Real-time PCR assay for MRSA
Active Comparator: Conventional culture
Conventional culture screen for detection of MRSA carriers upon hospital admission
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.
Other Names:
  • GeneXpert MRSA, Cepheid.
  • Real-time PCR assay for MRSA

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846105

Locations
Belgium
Algemeen Ziekenhuis Sint-Jan AV
Brugge, Belgium, B-8000
ULB Hopital Erasme
Brussels, Belgium, B-1070
Sponsors and Collaborators
Erasme University Hospital
Investigators
Principal Investigator: Marc J Struelens, MD, PhD Erasme University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Professor Marc J. Struelens, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT00846105     History of Changes
Other Study ID Numbers: Erasme-ULB-P2008/201
Study First Received: February 17, 2009
Last Updated: June 14, 2010
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Erasme University Hospital:
methicillin resistant Staphylococcus aureus
MRSA
cross-infection
staphylococcal infection
infection control

Additional relevant MeSH terms:
Communicable Diseases
Infection
Staphylococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014