Clinical trial
2013-10
Name
2013-10
Description
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 arms
Trial start
2013-06-07
Estimated PCD
2019-06-05
Trial end
2022-10-26
Status
Completed
Treatment
Blood Sample
Arms:
Patients with HLA-DQB1 06 and/or HLA-DRB 13
Size
246
Primary endpoint
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
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 246, 'type': 'ACTUAL'}}
Updated at
2023-04-21
1 organization
1 indication
Organization
Assistance Publique Hopitaux De MarseilleIndication
Tropheryma whipplei infection