Chronic Infection With Tropheryma Whipplei: Risk Factors Related to the Host
WHIPPLE
2 other identifiers
interventional
246
1 country
1
Brief Summary
In 2012, a previous work showed that T. whipplei is a common bacterium detected in various situations. A large part of the population is therefore exposed to a T. whipplei but there is that some people probably with immunological and genetic factors predisposing which develop a disease. The association teams with experience in HLA-typing will allow us to better identify patients with a risk of chronic complication. The main aim of this study is to evaluate if the HLA-DRB13 and/or HLA-DQB106 typing in patients are risk factors of chronic infection with T. whipplei (defined by classic Whipple disease and/ or, endocarditis and/or encephalitis).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2013
CompletedFirst Submitted
Initial submission to the registry
August 11, 2016
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2022
CompletedApril 21, 2023
April 1, 2023
6 years
August 11, 2016
April 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of patients with HLA-DQB1 06 among patients with a chronic infection with T. whipplei (defined by classic Whipple disease and / or endocarditis and/or encephalitis) versus asymptomatic patients
1 day
Proportion of patients with HLA-DRB 13 among patients with a chronic infection with T. whipplei (defined by classic Whipple disease and / or endocarditis and/or encephalitis) versus asymptomatic patients
1 day
Study Arms (1)
Patients with HLA-DQB1 06 and/or HLA-DRB 13
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patient with a positive PCR to T. Whipplei diagnostics.
- Patient aged \> or = 18 years old.
- Patient who does not declined to have his medical records reviewed for research.
- Patient with health insurance.
You may not qualify if:
- Patient minors (age \<18 years)
- Pregnant woman, parturient or breastfeeding
- Adult Patient under guardianship .
- Patient deprived of liberty under court order
- Patient refusing to sign the informed consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hôpitaux de Marseille
Marseille, 13005, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Catherine GEINDRE
Assistance Publiques Hôpitaux de Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2016
First Posted
August 16, 2016
Study Start
June 7, 2013
Primary Completion
June 5, 2019
Study Completion
October 26, 2022
Last Updated
April 21, 2023
Record last verified: 2023-04