- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01069497
Preventability of Infections in Residents of French Nursing Homes (ENLIL)
Impact of a Multifaceted Intervention on the Preventability of Infections in Residents of French Nursing Homes: Cluster-randomised Controlled Trial (ENLIL Study)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Nursing Homes
Comprising 24 nursing homes implementing a specific infection prevention program
|
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:
|
No Intervention: Usual care Nursing Homes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes
Time Frame: every month
|
every month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of death
Time Frame: every month
|
every month
|
Number of hospitalizations
Time Frame: every month
|
every month
|
Number of of prescriptions for antimicrobials
Time Frame: every month
|
every month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Monique Rothan Tondeur, PhD, ORIG, EHESP
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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