NCT03401242

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
734

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

October 3, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

January 3, 2018

Last Update Submit

April 12, 2019

Conditions

Enterobacteriaceae Infections

Keywords

CarbapenemaseEnterobacteriaceaeextended spectrum beta-lactamasesnursing homesprevalence

Outcome Measures

Primary Outcomes (1)

  • carbapenemase producing Enterobacteriaceae (CPE) carriage

    Assessment of CPE carriage through endorectal swabbing.

    six months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- Resident non-compliant with sampling protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

faecal samples

MeSH Terms

Conditions

Enterobacteriaceae Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Gabriel BIRGAND, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 17, 2018

Study Start

October 3, 2018

Primary Completion

January 14, 2019

Study Completion

January 14, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

FR(1)