Preventability of Infections in Residents of French Nursing Homes (ENLIL)

February 16, 2010 updated by: Observatoire du Risque Infectieux en Gériatrie

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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

3500

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Prevention of infections 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:

  • 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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Observatoire du Risque Infectieux en Gériatrie

Collaborators

Ministry of Health, France
Pierre Fabre Laboratories
Gaba Laboratories

Investigators

  • Principal Investigator: Monique Rothan Tondeur, PhD, ORIG, EHESP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

February 17, 2010

Last Update Submitted That Met QC Criteria

February 16, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

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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