NCT04085380

Brief Summary

The aim of this study is to identify in hospitalized patients, the risk factors associated with the digestive colonisation by emergent extensively drug-resistant bacteria (eXDR), to optimize their detection and the medical care for carriers these patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,396

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

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

September 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

September 9, 2019

Last Update Submit

October 7, 2020

Conditions

Risk Factor

Keywords

Clostridium difficileMultidrug resistant bacteriaRisks factorhighly resistant bacteriaeXDRESBL

Outcome Measures

Primary Outcomes (1)

  • Risk factors

    Identification of risk factors for digestive colonisation by highly resistant bacteria Lifestyle questionnaire: environment, diet, medical history and result of the rectal swab

    at inclusion

Secondary Outcomes (8)

  • Prevalence of multidrug-resistant bacteria will be determined by the number of patients who have been detected at least one multidrug-resistant bacteria referred to the number of patients sampled

    1 day

  • Prevalence of co-carrying patients of eXDR and ESBL will be determined by the number of patients who carrying eXDR and ESBL referred to the number of patients sampled

    1 day

  • Prevalence will be determined by the number of patients who carrying at least one Multidrug-resistant bacteria referred to the number of patients sampled

    1 day

  • Proportion of patients carrying "eXDR" who will develop an infection with the same germ referred to the number of eXDR carriers

    6 months

  • Cross-transmission rate of eXDR

    1 day

  • +3 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient hospitalized more than 24 hours, on a given day in one of the participating hospitals, is eligible to be included in the protocol, unless hospitalized in psychiatry

You may qualify if:

  • Hospitalization of more than 24 hours
  • Give his no objection

You may not qualify if:

  • Hospitalization in psychiatry
  • Unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HEGP

Paris, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Rectal swab

Study Officials

  • Najiby Kassis-Chikhani, PhD

    AP-HP, Hôpital Européen Georges Pompidou, Paris

    PRINCIPAL INVESTIGATOR

  • Jean-Ralph Zahar, PhD

    AP-HP, Hôpitaux Avicenne, Jean Verdier, et René Muret, Bobigny

    PRINCIPAL INVESTIGATOR

  • Véronique Moulin

    AP-HP, Hôpital Corentin Celton, et Vaugirard

    PRINCIPAL INVESTIGATOR

  • Pierre Frange, PhD

    AP-HP, Hôpital Necker enfants malades, Paris

    PRINCIPAL INVESTIGATOR

  • Christine Lawrence, PhD

    AP-HP, Hôpital Raymond Poincaré, Garches

    PRINCIPAL INVESTIGATOR

  • Frédéric Barbut, PhD

    AP-HP-Hôpital Saint Antoine, Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 11, 2019

Study Start

September 16, 2019

Primary Completion

January 16, 2020

Study Completion

July 10, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
one year after the last publication
Access Criteria
Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization

Locations

FR(1)