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

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Unknown status
CT.gov ID
NCT02819128
Collaborator
(none)
510
1
1
49.9
10.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Swabs skin, pharyngeal, and blood sample
  • Other: Collection of body lice
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
510 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Investigation of Endemic and Emerging Diseases in Populations of Homeless Households in Marseille.
Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Sep 1, 2017
Anticipated Study Completion Date :
Mar 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Percentage of subjects with an established microbiological diagnosis [3 years]

Secondary Outcome Measures

  1. Prevalence of skin infections [1 day]

  2. Prevalence of Tropheryma whipplei infections [1 day]

  3. Prevalence of infestation by body lice [1 day]

  4. Percentage of body lice resistant to permethrin [1 day]

  5. Prevalence of infections by Bartonella quintana [1 day]

  6. Prevalence of infection by hepatitis E and C [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 ) .

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assistance Publique Hopitaux de Marseille Marseille France 13354

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Philippe BROUQUI, Pr, Assistance Publique - Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT02819128
Other Study ID Numbers:
  • 2013-44
First Posted:
Jun 30, 2016
Last Update Posted:
Jun 30, 2016
Last Verified:
Jun 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided

Study Results

No Results Posted as of Jun 30, 2016