Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis

Not Applicable

Completed

• Conditions: Subjects Clinically Suspected an Active Source of Toxoplasmosis Chorioretinitis Infection
• Interventions: Other: Fluorescein angiography; Other: Dilated fundus examination; Biological: Toxoplasmosis serology; Drug: Anti-toxoplasmosis treatment; Drug: Anti-inflammatory treatments; Other: Puncture in anterior chamber

• Registration Number: NCT02843438
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-07
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-22
• Last Update Submitted: 2016-07-22
• Study First Posted: 2016-07-25
• Last Update Posted: 2016-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

• Age over 18 years
• Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection
• Persons affiliated to national social security

Exclusion Criteria

• Pregnant, parturient or breastfeeding women
• Persons deprived of liberty by judicial or administrative decision, person under legal protection
• Refusal by a patient to do the PCA (anterior chamber puncture)
• Patients whose following will be difficult or nonexistent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects suspected of toxoplasmosis chorioretinitis infection	Fluorescein angiography	Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection
Subjects suspected of toxoplasmosis chorioretinitis infection	Dilated fundus examination	Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection
Subjects suspected of toxoplasmosis chorioretinitis infection	Toxoplasmosis serology	Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection
Subjects suspected of toxoplasmosis chorioretinitis infection	Anti-toxoplasmosis treatment	Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection
Subjects suspected of toxoplasmosis chorioretinitis infection	Anti-inflammatory treatments	Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection
Subjects suspected of toxoplasmosis chorioretinitis infection	Puncture in anterior chamber	Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection

Primary Outcome Measures

Name	Time	Method
ELISA tests	About an hour	ELISA (enzyme linked immunosorbent assay) tests. Biological markers evaluation : stress protein Hsp70 and antibodies anti-Hsp70.

Trial Locations

Locations (1)

UniversityHospitalGrenoble; 🇫🇷 La Tronche, France