NCT00151606

Brief Summary

Nosocomial infections is a major problem in intensive care units due to both growing incidence and pathogens implicated which become increasingly resistant to antibiotics. According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for approximately 10% of cases. In Europe, 79% of the S.aureus strains are resistant to methicillin, a routinely used antibiotic. Recommendations for the prevention of transmission of these resistant bacteria are rarely based on controlled trials. Therefore the aim of our study is to evaluate two protocols to prevent the acquisition of methicillin-resistant S. Aureus in intensive care units: either a reinforced isolation precautions protocol or a standard precautions protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2002

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

December 1, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

January 10, 2006

Status Verified

January 1, 2006

First QC Date

September 8, 2005

Last Update Submit

January 9, 2006

Conditions

Nosocomial InfectionsMRSA Colonization

Keywords

Infection preventionIsolationResistant bacteriaMRSA colonization

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.

Secondary Outcomes (8)

  • - Rate of nosocomial MRSA infections

  • - Rate of nosocomial infections due to other pathogens

  • - Rate of nosocomial infections according to the site

  • - Death rate at the exit of intensive care unit

  • - Additional cost due to reinforced isolation protocol

  • +3 more secondary outcomes

Interventions

Reinforced isolation + MuciprocinePROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Adults over 18 years
  • Expected length of stay \> 48h in intensive care unit
  • Informed written consent

You may not qualify if:

  • Cerebral death
  • Care limitation
  • Neutropenia
  • Documented MRSA on admission
  • Patients receiving antistaphylococcal topical antibiotics on admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou

Rennes, 35033, France

Location

Service de Réanimation Médicale - Hôpital Bretonneau

Tours, 37000, France

Location

Related Publications (4)

  • Chaix C, Durand-Zaleski I, Alberti C, Brun-Buisson C. Control of endemic methicillin-resistant Staphylococcus aureus: a cost-benefit analysis in an intensive care unit. JAMA. 1999 Nov 10;282(18):1745-51. doi: 10.1001/jama.282.18.1745.

    PMID: 10568647BACKGROUND

  • Girou E, Pujade G, Legrand P, Cizeau F, Brun-Buisson C. Selective screening of carriers for control of methicillin-resistant Staphylococcus aureus (MRSA) in high-risk hospital areas with a high level of endemic MRSA. Clin Infect Dis. 1998 Sep;27(3):543-50. doi: 10.1086/514695.

    PMID: 9770155BACKGROUND

  • Camus C, Bellissant E, Sebille V, Perrotin D, Garo B, Legras A, Renault A, Le Corre P, Donnio PY, Gacouin A, Le Tulzo Y, Thomas R. Prevention of acquired infections in intubated patients with the combination of two decontamination regimens. Crit Care Med. 2005 Feb;33(2):307-14. doi: 10.1097/01.ccm.0000152224.01949.01.

    PMID: 15699832RESULT

  • Camus C, Bellissant E, Legras A, Renault A, Gacouin A, Lavoue S, Branger B, Donnio PY, le Corre P, Le Tulzo Y, Perrotin D, Thomas R. Randomized comparison of 2 protocols to prevent acquisition of methicillin-resistant Staphylococcus aureus: results of a 2-center study involving 500 patients. Infect Control Hosp Epidemiol. 2011 Nov;32(11):1064-72. doi: 10.1086/662180. Epub 2011 Sep 29.

    PMID: 22011532DERIVED

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christophe Camus, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

  • Eric Bellissant, MD, PhD

    Rennes University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

December 1, 2002

Study Completion

February 1, 2004

Last Updated

January 10, 2006

Record last verified: 2006-01

Locations

FR(2)