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Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.

Primary Purpose

Nosocomial Infections, MRSA Colonization

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Reinforced isolation + Muciprocine
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nosocomial Infections focused on measuring Infection prevention, Isolation, Resistant bacteria, MRSA colonization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults over 18 years Expected length of stay > 48h in intensive care unit Informed written consent Exclusion Criteria: Cerebral death Care limitation Neutropenia Documented MRSA on admission Patients receiving antistaphylococcal topical antibiotics on admission

Sites / Locations

  • Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou
  • Service de Réanimation Médicale - Hôpital Bretonneau

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

- 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
- Antistaphylococcal antibiotics use in both protocols
- Number of days of antibiotherapy
- Time and cause of septic isolation

Full Information

First Posted
September 8, 2005
Last Updated
January 9, 2006
Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00151606
Brief Title
Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.
Official Title
Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France

4. Oversight

5. Study Description

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.
Detailed Description
Recommendations for the prevention of transmission of resistant bacteria in intensive care units (ICU) are rarely based on controlled trials. For this reason, we compared a reinforced isolation precautions protocol (RIPP) with a standard precautions protocol (SPP) for the acquisition of methicillin-resistant Staphylococcus aureus (MRSA) in 2 intensive care units. Evaluation: the risk for MRSA carriage was defined on admission if 1 of 3 criteria were met: hospitalization in the past year, transfer with prior length of stay ≥2 days, prior history of MRSA in the 5 past years. Intervention: Randomization 1/1 of a total of 500 patients to either protocol; MRSA screening was performed at the sites of carriage and colonization at inclusion, every week and at ICU discharge in all patients; the results were given to the clinicians only for the patients of the RIPP group. Protocols: the SPP was consistent with the CDC recommendations and included transmission-based isolation precautions to patients with clinical samples involving resistant bacteria (including MRSA) or highly transmissible organisms. The RIPP included the extension of isolation precautions (1) to patients at risk for MRSA on admission until screening results proved negative and (2) to MRSA-positive patients on screening or clinical samples until further negative samples, in whom nasal mupirocin decontamination was added. Compliance with the recommendations of each protocol was controlled by an audit. The efficacy is assessed on the proportion of patients who acquired MRSA at any site.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Infections, MRSA Colonization
Keywords
Infection prevention, Isolation, Resistant bacteria, MRSA colonization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Reinforced isolation + Muciprocine
Primary Outcome Measure Information:
Title
Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
Secondary Outcome Measure Information:
Title
- Rate of nosocomial MRSA infections
Title
- Rate of nosocomial infections due to other pathogens
Title
- Rate of nosocomial infections according to the site
Title
- Death rate at the exit of intensive care unit
Title
- Additional cost due to reinforced isolation protocol
Title
- Antistaphylococcal antibiotics use in both protocols
Title
- Number of days of antibiotherapy
Title
- Time and cause of septic isolation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults over 18 years Expected length of stay > 48h in intensive care unit Informed written consent Exclusion Criteria: Cerebral death Care limitation Neutropenia Documented MRSA on admission Patients receiving antistaphylococcal topical antibiotics on admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Camus, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Bellissant, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Service de Réanimation Médicale - Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
10568647
Citation
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.
Results Reference
background
PubMed Identifier
9770155
Citation
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.
Results Reference
background
PubMed Identifier
15699832
Citation
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.
Results Reference
result
PubMed Identifier
22011532
Citation
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.
Results Reference
derived

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Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.

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