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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02819128
Other study ID # 2013-44
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 25, 2014
Est. completion date October 26, 2022

Study information

Verified date April 2023
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 722
Est. completion date October 26, 2022
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Endemic and Emerging Diseases in Populations of Homeless

Intervention

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 ).
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.

Locations

Country Name City State
France Assistance Publique Hopitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of subjects with an established microbiological diagnosis 3 years
Secondary Prevalence of skin infections 1 day
Secondary Prevalence of Tropheryma whipplei infections 1 day
Secondary Prevalence of infestation by body lice 1 day
Secondary Percentage of body lice resistant to permethrin 1 day
Secondary Prevalence of infections by Bartonella quintana 1 day
Secondary Prevalence of infection by hepatitis E and C 1 day