Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis (BIOLUVE)
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|ClinicalTrials.gov Identifier: NCT02843438|
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Toxoplasmosis affects one to two newborn each 10000 births. Among them, 1 to 2 % develop learning disabilities or die, and 4 to 27 % develop a chorioretinitis sometimes leading to an amblyopia responsible for visual impairment. Toxoplasmosis uveitis affects too adults immunocompetent and immunodepressed who have had an acquired toxoplasmosis. Clinical diagnosis of ocular toxoplasmosis is more complicated in presence of posterior neuro-retinitis, inflammation of the papilla, uveitis without chorioretinitis, fuchs heterochromic iridocyclitis, scleritis, diffuse necrotizing or multifocal retinitis. In this situation biological markers diagnostic and prognostic of toxoplasmosis uveitis are useful.
Highly kept molecules (during evolution) like stress proteins (Hsp) are are found in the host and the pathogen and there can trigger a crossed immune response. Stress proteins haven't been explored yet, in the context of toxoplasmosis uveitis on humans.
The hypothesis is that Hsp70 and antibodies anti-Hsp70 are diagnostic and prognostic markers of ocular toxoplasmosis.
The goal is to evaluate diagnosis value of biological markers (Hsp70 and antibodies IgG anti-Hsp70) in toxoplasmosis uveitis.
|Condition or disease||Intervention/treatment||Phase|
|Subjects Clinically Suspected an Active Source of Toxoplasmosis Chorioretinitis Infection||Other: Fluorescein angiography Other: Dilated fundus examination Biological: Toxoplasmosis serology Drug: Anti-toxoplasmosis treatment Drug: Anti-inflammatory treatments Other: Puncture in anterior chamber||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Subjects suspected of toxoplasmosis chorioretinitis infection
Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection
Other: Fluorescein angiography
Other: Dilated fundus examination
Biological: Toxoplasmosis serology
Drug: Anti-toxoplasmosis treatment
Drug: Anti-inflammatory treatments
Other: Puncture in anterior chamber
- ELISA tests [ Time Frame: About an hour ]ELISA (enzyme linked immunosorbent assay) tests. Biological markers evaluation : stress protein Hsp70 and antibodies anti-Hsp70.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843438
|La Tronche, France, 38700|
|Principal Investigator:||Laurence Bouillet, Professor||Grenoble Hospital University|