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

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ClinicalTrials.gov Identifier: NCT01069497
Recruitment Status : Unknown
Verified September 2009 by Observatoire du Risque Infectieux en Gériatrie.
Recruitment status was:  Active, not recruiting
First Posted : February 17, 2010
Last Update Posted : February 17, 2010
Sponsor:
Collaborators:
Ministry of Health, France
Pierre Fabre Laboratories
Gaba Laboratoires
Information provided by:
Observatoire du Risque Infectieux en Gériatrie

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.


Condition or disease Intervention/treatment Phase
Infection Control Other: Prevention of infections program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3500 participants
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)
Study Start Date : November 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


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



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

Secondary Outcome Measures :
  1. Number of death [ Time Frame: every month ]
  2. Number of hospitalizations [ Time Frame: every month ]
  3. Number of of prescriptions for antimicrobials [ Time Frame: every month ]


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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

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 Posted: February 17, 2010    Key Record Dates
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