Infection ControlENLILNCT01069497
Preventability of Infections in Residents of French Nursing Homes
A study testing Prevention of infections program in people with Infection Control, run by Observatoire du Risque Infectieux en Gériatrie.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infection Control
- What is being tested?
- Prevention of infections program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nursing homes where a prevention program has already been implemented
About this study
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 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.
- Conditions
- Infection Control
- Being tested
- Prevention of infections program
- Keywords
- Infection control, Urinary Tract Infections, Respiratory Tract Infections
- Medical subject headings
- Urinary Tract Infections, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention of infections programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Nursing Homes | Experimental | Comprising 24 nursing homes implementing a specific infection prevention program Receives: Other: Prevention of infections program |
| Usual care Nursing Homes | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes
Measured: every month
Secondary outcomes (3)
Number of death
Measured: every month
Number of hospitalizations
Measured: every month
Number of of prescriptions for antimicrobials
Measured: every month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infection ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Observatoire du Risque Infectieux en Gériatrie
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Pierre Fabre Laboratories, Gaba Laboratories
- Investigators
- Monique Rothan Tondeur, PhD, Principal investigator, ORIG, EHESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069497
- Sponsor's protocol ID
- V15
- Acronym
- ENLIL
- Status last verified
- Sep 2009
- First submitted
- 16 Feb 2010
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multifaceted Intervention on the Preventability of Infections in Residents of French Nursing Homes: Cluster-randomised Controlled Trial (ENLIL Study)
- ClinicalTrials.gov ID
- NCT01069497
- Acronym / sponsor ID
- ENLIL / V15
- Conditions
- Infection Control
- Keywords
- Infection control, Urinary Tract Infections, Respiratory Tract Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Observatoire du Risque Infectieux en GériatrieUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Pierre Fabre Laboratories, Gaba Laboratories
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Nursing Homes | Experimental | Other: Prevention of infections programComprising 24 nursing homes implementing a specific infection prevention program |
| Usual care Nursing Homes | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Nursing homes where a prevention program has already been implemented
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention of infections programThe 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. | Other | Intervention Nursing Homes |
Primary outcome
Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes
Time frame: every month
3 secondary outcomes
Number of death
Time frame: every month
Number of hospitalizations
Time frame: every month
Number of of prescriptions for antimicrobials
Time frame: every month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
- Derived from this study: PubMed 22682697Chami 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique Rothan Tondeur, PhD principal investigator
ORIG, EHESP
Questions about this trial
What is this clinical trial studying?
A study testing Prevention of infections program in people with Infection Control, run by Observatoire du Risque Infectieux en Gériatrie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes (time frame: every month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01069497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2010.