Overview

This trial is active, not recruiting.

Condition infection control
Treatment prevention of infections program
Sponsor Observatoire du Risque Infectieux en Gériatrie
Collaborator Ministry of Health, France
Start date November 2009
End date April 2010
Trial size 3500 participants
Trial identifier NCT01069497, V15

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Comprising 24 nursing homes implementing a specific infection prevention program
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)

Primary Outcomes

Measure
Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes
time frame: every month

Secondary Outcomes

Measure
Number of death
time frame: every month
Number of hospitalizations
time frame: every month
Number of of prescriptions for antimicrobials
time frame: every month

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Impact of a Multifaceted Intervention on the Preventability of Infections in Residents of French Nursing Homes: Cluster-randomised Controlled Trial (ENLIL Study)
Principal investigator Monique Rothan Tondeur, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Observatoire du Risque Infectieux en Gériatrie.