Investigation of Endemic and Emerging Diseases in Populations of Homeless Households in Marseille. (SDF)

April 20, 2023 updated by: Assistance Publique Hopitaux De Marseille

Hypothesis:

Homeless people have infections not diagnosed with a potential impact on their health status.

Main Purpose: Improve the etiological diagnosis of endemic and/or emerging pathologies among homeless people.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In Marseilles, the population of homeless is estimated at 1500 individuals, including 800 usually sleeping in the street, 600 in foster homes and a hundred in the structures of care. The precarious living conditions of homeless persons promote the emergence or re-emergence of many communicable infectious diseases homeless people whose symptoms are often overlooked by the subject and rarely established etiologic diagnosis.

Among these diseases, frequently described in the literature are infestation by lice and infectious diseases that they transmit (Bartonella quintana), skin infections, hepatitis E and C and finally the infection with Tropheryma Whipplei. In this study we propose to systematically in homeless subject an etiological diagnosis of pathogens at the origin of these diseases (i) to improve knowledge (ii) to improve their management, (iii) to limit the contagion.

Study Type

Interventional

Enrollment (Actual)

722

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Homeless Subject on the day of the study in one of two shelters for homeless Marseille ( Madrague City and Forbin )
  • Major subject ( > or equal to 18 years)
  • Freely about having signed the written informed consent,
  • About affiliated with a social security scheme

Exclusion Criteria:

  • Minor Subjects ( < 18 years )
  • Major subject under guardianship (L. 1121-8 )
  • Subject privated of freedom or under court order (L. 1121-6 )
  • Subject refusing to sign the informed consent form ,
  • Subject not affiliated with a social security insurance
  • Pregnant women , parturient or nursing (L. 1121-7 ) .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Homeless people
Populations of homeless households in Marseille.
Other: Swabs skin, pharyngeal, and blood sample
Collection of one blood sample with a volume of 10 mL (2 tubes of blood 5 mL ) and 2 swabs ( throat and skin ).
Other: Collection of body lice
For the subjects infested with body lice , if they want, their underwear will be recovered and sent to the laboratory to measure the resistance to permethrin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with an established microbiological diagnosis
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of skin infections
Time Frame: 1 day
1 day
Prevalence of Tropheryma whipplei infections
Time Frame: 1 day
1 day
Prevalence of infestation by body lice
Time Frame: 1 day
1 day
Percentage of body lice resistant to permethrin
Time Frame: 1 day
1 day
Prevalence of infections by Bartonella quintana
Time Frame: 1 day
1 day
Prevalence of infection by hepatitis E and C
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2014

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

October 26, 2022

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2013-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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