Back to resultsPreventability of Infections in Residents of French Nursing Homes (ENLIL)
Primary Purpose
Infection Control
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prevention of infections program
Sponsored by
About this trial
This is an interventional prevention trial for Infection Control focused on measuring Infection control, Urinary Tract Infections, Respiratory Tract Infections
Eligibility Criteria
Inclusion Criteria:
- Nursing homes which contain a medical coordinator and at least one nurse and/or nursing auxiliary.
- Nursing Homes located in France (North-West)
- All the residents present or entering the facility during the study period
Exclusion Criteria:
- Nursing homes where a prevention program has already been implemented
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Nursing Homes
Usual care Nursing Homes
Arm Description
Comprising 24 nursing homes implementing a specific infection prevention program
Outcomes
Primary Outcome Measures
Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes
Secondary Outcome Measures
Number of death
Number of hospitalizations
Number of of prescriptions for antimicrobials
Full Information
NCT ID
NCT01069497
First Posted
February 16, 2010
Last Updated
February 16, 2010
Sponsor
Observatoire du Risque Infectieux en Gériatrie
Collaborators
Ministry of Health, France, Pierre Fabre Laboratories, Gaba Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT01069497
Brief Title
Preventability of Infections in Residents of French Nursing Homes
Acronym
ENLIL
Official Title
Impact of a Multifaceted Intervention on the Preventability of Infections in Residents of French Nursing Homes: Cluster-randomised Controlled Trial (ENLIL Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Observatoire du Risque Infectieux en Gériatrie
Collaborators
Ministry of Health, France, Pierre Fabre Laboratories, Gaba Laboratories
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
STUDY HYPOTHESIS : An infection prevention program adapted for the nursing home context can reduce by 5% the number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes.
STUDY DESIGN : The proposal is for an interventional cluster (nursing home) study comprising 2 randomized groups: group 1 (interventional), comprising 25 nursing homes implementing a specific infection prevention program; and group 2 (control), 25 nursing homes continuing to implement their routine prevention measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection Control
Keywords
Infection control, Urinary Tract Infections, Respiratory Tract Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Nursing Homes
Arm Type
Experimental
Arm Description
Comprising 24 nursing homes implementing a specific infection prevention program
Arm Title
Usual care Nursing Homes
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Prevention of infections program
Intervention Description
The intervention mainly involves implementing urinary, respiratory and gastrointestinal infection prevention measures. Study nursing home medical coordinators will be in charge of training their own teams. For this, they will be provided with:
a slide-show of recommendations (commented by an expert),
recommendations guides (on paper and on computer) to be shown to their teams. Means will be provided to the intervention nursing homes : Hydro-alcoholic solutions, disinfectant detergent-impregnated tissues, mouth care kits, tec.
Primary Outcome Measure Information:
Title
Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes
Time Frame
every month
Secondary Outcome Measure Information:
Title
Number of death
Time Frame
every month
Title
Number of hospitalizations
Time Frame
every month
Title
Number of of prescriptions for antimicrobials
Time Frame
every month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Nursing homes which contain a medical coordinator and at least one nurse and/or nursing auxiliary.
Nursing Homes located in France (North-West)
All the residents present or entering the facility during the study period
Exclusion Criteria:
Nursing homes where a prevention program has already been implemented
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monique Rothan Tondeur, PhD
Organizational Affiliation
ORIG, EHESP
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22682697
Citation
Chami K, Gavazzi G, Bar-Hen A, Carrat F, de Wazieres B, Lejeune B, Armand N, Rainfray M, Hajjar J, Piette F, Rothan Tondeur M. A short-term, multicomponent infection control program in nursing homes: a cluster randomized controlled trial. J Am Med Dir Assoc. 2012 Jul;13(6):569.e9-17. doi: 10.1016/j.jamda.2012.04.008. Epub 2012 Jun 7.
Results Reference
derived
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Preventability of Infections in Residents of French Nursing Homes
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