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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Observatoire du Risque Infectieux en Gériatrie.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069497
First Posted: February 17, 2010
Last Update Posted: February 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ministry of Health, France
Pierre Fabre Laboratories
Gaba Laboratoires
Information provided by:
Observatoire du Risque Infectieux en Gériatrie
  Purpose

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.


Condition Intervention
Infection Control Other: Prevention of infections program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of a Multifaceted Intervention on the Preventability of Infections in Residents of French Nursing Homes: Cluster-randomised Controlled Trial (ENLIL Study)

Resource links provided by NLM:


Further study details as provided by Observatoire du Risque Infectieux en Gériatrie:

Primary Outcome Measures:
  • Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes [ Time Frame: every month ]

Secondary Outcome Measures:
  • Number of death [ Time Frame: every month ]
  • Number of hospitalizations [ Time Frame: every month ]
  • Number of of prescriptions for antimicrobials [ Time Frame: every month ]

Estimated Enrollment: 3500
Study Start Date: November 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069497


Sponsors and Collaborators
Observatoire du Risque Infectieux en Gériatrie
Ministry of Health, France
Pierre Fabre Laboratories
Gaba Laboratoires
Investigators
Principal Investigator: Monique Rothan Tondeur, PhD ORIG, EHESP
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Monique Rothan-Tondeur, Observatoire du Risque Infectieux en Gériatrie
ClinicalTrials.gov Identifier: NCT01069497     History of Changes
Other Study ID Numbers: V15
First Submitted: February 16, 2010
First Posted: February 17, 2010
Last Update Posted: February 17, 2010
Last Verified: September 2009

Keywords provided by Observatoire du Risque Infectieux en Gériatrie:
Infection control
Urinary Tract Infections
Respiratory Tract Infections

Additional relevant MeSH terms:
Infection
Communicable Diseases