NCT00846105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 15, 2010

Status Verified

June 1, 2010

Enrollment Period

1 year

First QC Date

February 17, 2009

Last Update Submit

June 14, 2010

Conditions

Methicillin ResistanceStaphylococcus AureusStaphylococcal Infection

Keywords

methicillin resistant Staphylococcus aureusMRSAcross-infectionstaphylococcal infectioninfection control

Outcome Measures

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

    5-10 months

Secondary Outcomes (6)

  • Median time required for detection of MRSA carriage after admission

    5-10 months

  • Median time required for starting isolation of MRSA carriers

    5-10 months

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

    5-10 months

  • MRSA nosocomial infection rate

    5-10 months

  • MRSA cross-transmission rate

    5-10 months

  • +1 more secondary outcomes

Study Arms (2)

Rapid PCR screen

EXPERIMENTAL

Rapid PCR screen test for detection of MRSA carriers upon hospital admission

Other: Rapid MRSA PCR test for screening carriers

Conventional culture

ACTIVE COMPARATOR

Conventional culture screen for detection of MRSA carriers upon hospital admission

Other: Rapid MRSA PCR test for screening carriers

Interventions

Rapid MRSA PCR test for screening carriersOTHER

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.

Also known as: GeneXpert MRSA, Cepheid., Real-time PCR assay for MRSA
Conventional cultureRapid PCR screen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients staying 48h or less in the study wards

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Algemeen Ziekenhuis Sint-Jan AV

Bruges, B-8000, Belgium

Location

ULB Hopital Erasme

Brussels, B-1070, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 16563177BACKGROUND

  • 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.

    PMID: 24836438DERIVED

MeSH Terms

Conditions

Staphylococcal InfectionsCross Infection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marc J Struelens, MD, PhD

    Erasme University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 18, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2010

Study Completion

May 1, 2010

Last Updated

June 15, 2010

Record last verified: 2010-06

Locations

BE(2)