CClinicalTrials.gg
Status unknownNCT01069497ENLILUpdated Feb 17, 2010

Preventability of Infections in Residents of French Nursing Homes

An interventional study of Prevention of infections program in Infection Control, sponsored by Observatoire du Risque Infectieux en Gériatrie. Status unknown. Per ClinicalTrials.gov, last updated 2010-02-17.

Sponsored by Observatoire du Risque Infectieux en Gériatrie · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
3,500
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Infection Control

Keywords

  • Infection control
  • Urinary Tract Infections
  • Respiratory Tract Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 3,500 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

This is the only study on the registry with Observatoire du Risque Infectieux en Gériatrie as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Nursing homes where a prevention program has already been implemented
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,500 participants (estimated)

Study arms

  • Experimental
    Intervention Nursing Homes

    Comprising 24 nursing homes implementing a specific infection prevention program

    Other: Prevention of infections program

  • No intervention
    Usual care Nursing Homes

Interventions

  • OtherPrevention 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.

06

What researchers measure

Primary outcomes

  1. Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes

    Time frame: every month

Secondary outcomes

  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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Chami K, Gavazzi G, Bar-Hen A, Carrat F, de Wazieres B, Lejeune B, Armand N, Rainfray M, Hajjar J, Piette F, Rothan Tondeur M. A short-term, multicomponent infection control program in nursing homes: a cluster randomized controlled trial. J Am Med Dir Assoc. 2012 Jul;13(6):569.e9-17. doi: 10.1016/j.jamda.2012.04.008. Epub 2012 Jun 7. PubMed 22682697 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01069497
Lead sponsor
Observatoire du Risque Infectieux en Gériatrie
Collaborators
Ministry of Health, France, Pierre Fabre Laboratories, Gaba Laboratories
First posted
Feb 17, 2010
Start date
Nov 2009
Primary completion
Apr 2010 (estimated)
Completion
Apr 2010 (estimated)
Last update
Feb 17, 2010

Study contacts

Monique Rothan Tondeur, PhD
principal investigator · ORIG, EHESP

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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