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CompletedNCT03401242CARBEHPADUpdated Apr 16, 2019

Prevalence of ESBL and CPE in French Nursing Homes

An observational study in Enterobacteriaceae Infections, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-16.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
734
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Enterobacteriaceae Infections with a site in France — 3 open to participants now, 3 under way, 1 of them phase 3. Enterobacteriaceae Infections · France.

Started
2018
with 1 other
Observational
9 of 12
2 open now
Registered
3rd of 12
by date
Lead sponsor
1 of 12
Nantes University Hospital

Among the 12 studies in Enterobacteriaceae Infections with a site in France, this one is one of 2 that started in 2018, is one of 9 observational ones, and was the 3rd registered.

Enterobacteriaceae Infections

59 studies on the registry are indexed under Enterobacteriaceae Infections; 14 are open to participants now.

Browse Enterobacteriaceae Infections studies →

Open to participants now

3 of the 12 studies in Enterobacteriaceae Infections with a site in France are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 9 Enterobacteriaceae Infections studies recruiting now, 4 set no upper age limit and 2 stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study summary

CARBEHPAD is a multicentric randomized prevalence study aiming to assess the frequency of Enterobacteriaceae (ESLB) and carbapenemase producing Enterobacteriaceae (CPE) carriage in Pays de la Loire nursing homes.

A sample of 50 nursing homes (NH) in Pays de la Loire will be randomly selected for inclusion, and a sample of 1/3 of residents of these NH will be screened for ESBL and/or CPE fecal carriage. Epidemiological data on each resident will be collected to identify risk factors for such carriage.

Read the detailed description

The Pays de la Loire region is impacted by 2 main CPE outbreaks in the 2 major university hospitals in this region. A sample of 50 nursing homes (NH) in Pays de la Loire region (France) will be randomly selected for inclusion in CARBEHPAD study. NH directors will be contacted for agreement for inclusion in CARBEHPAD study. In each of the included NH, a sample of one third of residents will be randomly selected for inclusion. Upon agreement, each resident included will be screened through endorectal swabbing for ESBL and/or CPE carriage.

Epidemiological data will be collected for each resident regarding demographic data, risk factors for ESBL and/or CPE carriage, comorbidities. These data collected in the NH will be completed with data collection from national NH database regarding: previous hospitalization, treatments (including antibiotics), surgery.

Data on infection control and prevention will be collected in each NH to assess cross transmission of resistant bacteria in these settings.

Comparison of isolated strains will be performed to assess clonal dissemination of these resistant Enterobacteriaceae in NH. Data regarding infection control and prevention in each included NH will be collected aswell.

An ESBL/CPE carrier status has no impact on medical care in NH regarding French recommendations on management of such resistant microorganisms.

03

Conditions studied

  • Enterobacteriaceae Infections

Keywords

  • Carbapenemase
  • Enterobacteriaceae
  • extended spectrum beta-lactamases
  • nursing homes
  • prevalence
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

1000 residents of the nursing homes of the 5 departments of Pays de la Loire will be included in this study protocol.

Participants in the study will be randomly sampled according to a two-stage sampling design.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Resident present in the nursing home on the day of the survey.
  • Resident having agreed to be included in the study.
  • Resident with a social security number.

Exclusion criteria

Exclusion Criteria:

  • Resident non-compliant with sampling protocol.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
734 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. carbapenemase producing Enterobacteriaceae (CPE) carriage

    Assessment of CPE carriage through endorectal swabbing.

    Time frame: six months

07

Study locations

1 site
  • Nantes University Hospital
    Nantes, 44093, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2018 to primary completion in Jan 2019, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 3, 2018
First posted
Jan 17, 2018
StartActual
Oct 3, 2018
Primary completionActual
Jan 14, 2019
CompletionActual
Jan 14, 2019
Last update
Apr 16, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03401242
Responsible party
Sponsor
First posted
Jan 17, 2018
Start date
Oct 3, 2018
Primary completion
Jan 14, 2019
Completion
Jan 14, 2019
Last update
Apr 16, 2019

Study contacts

Gabriel BIRGAND, Dr
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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