Skip to main content
OpenTrials
Completed

NCT Number: NCT00846105

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Methicillin Resistance Bacterial Infections Bacterial Infections and Mycoses Cross Infection Disease Attributes Gram-Positive Bacterial Infections Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Staphylococcal Infection Staphylococcal Infections Staphylococcus Aureus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Algemeen Ziekenhuis Sint-Jan AV, Bruges, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid MRSA PCR test for screening carriers

Other

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

Primary outcomes

  1. 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 outcomes

  1. Median time required for detection of MRSA carriage after admission

    Time frame: 5-10 months

  2. Median time required for starting isolation of MRSA carriers

    Time frame: 5-10 months

  3. Number of patient-days of MRSA carrier stay in non-isolated conditions

    Time frame: 5-10 months

  4. MRSA nosocomial infection rate

    Time frame: 5-10 months

  5. MRSA cross-transmission rate

    Time frame: 5-10 months

  6. Sensitivity and specificity of PCR vs conventional MRSA screening by culture

    Time frame: 10 months

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 18, 2009
Registry last updated
Jun 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.