Endemic and Emerging Diseases in Populations of HomelessSDFNCT02819128
Investigation of Endemic and Emerging Diseases in Populations of Homeless Households in Marseille.
A study testing Swabs skin, pharyngeal, and blood sample and Collection of body lice in people with Endemic and Emerging Diseases in Populations of Homeless, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endemic and Emerging Diseases in Populations of Homeless
- What is being tested?
- Swabs skin, pharyngeal, and blood sample and Collection of body lice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 722 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2014to 26 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 ) .
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Swabs skin, pharyngeal, and blood sample, Collection of body lice
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swabs skin, pharyngeal, and blood sampleOther
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 liceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Homeless people | Other | Populations of homeless households in Marseille. Receives: Other: Swabs skin, pharyngeal, and blood sample; Other: Collection of body lice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with an established microbiological diagnosis
Measured: 3 years
Secondary outcomes (6)
Prevalence of skin infections
Measured: 1 day
Prevalence of Tropheryma whipplei infections
Measured: 1 day
Prevalence of infestation by body lice
Measured: 1 day
Percentage of body lice resistant to permethrin
Measured: 1 day
Prevalence of infections by Bartonella quintana
Measured: 1 day
Prevalence of infection by hepatitis E and C
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start25 Jan 2014
- Primary completion30 Sep 2020
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endemic and Emerging Diseases in Populations of HomelessStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe BROUQUI, Pr, Principal investigator, Assistance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819128
- Sponsor's protocol ID
- 2013-44
- Acronym
- SDF
- Status last verified
- Apr 2023
- First submitted
- 28 Jun 2016
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Endemic and Emerging Diseases in Populations of Homeless Households in Marseille.
- ClinicalTrials.gov ID
- NCT02819128
- Acronym / sponsor ID
- SDF / 2013-44
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 25 Jan 2014 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Homeless people | Other | Other: Swabs skin, pharyngeal, and blood sample, Other: Collection of body licePopulations of homeless households in Marseille. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swabs skin, pharyngeal, and blood sampleCollection of one blood sample with a volume of 10 mL (2 tubes of blood 5 mL ) and 2 swabs ( throat and skin ). | Other | Homeless people |
| Collection of body liceFor 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. | Other | Homeless people |
Primary outcome
Percentage of subjects with an established microbiological diagnosis
Time frame: 3 years
6 secondary outcomes
Prevalence of skin infections
Time frame: 1 day
Prevalence of Tropheryma whipplei infections
Time frame: 1 day
Prevalence of infestation by body lice
Time frame: 1 day
Percentage of body lice resistant to permethrin
Time frame: 1 day
Prevalence of infections by Bartonella quintana
Time frame: 1 day
Prevalence of infection by hepatitis E and C
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe BROUQUI, Pr principal investigator
Assistance Publique - Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swabs skin, pharyngeal, and blood sample and Collection of body lice in people with Endemic and Emerging Diseases in Populations of Homeless, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with an established microbiological diagnosis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.