BIOLUVE: Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT02843438

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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