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OpenTrials
Completed

NCT Number: NCT02843438

Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis

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.

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Key information

Conditions

Subjects Clinically Suspected an Active Source of Toxoplasmosis Chorioretinitis Infection Chorioretinitis Choroid Diseases Choroiditis Coccidiosis Eye Diseases Infections Panuveitis Parasitic Diseases Protozoan Infections Retinal Diseases Retinitis Toxoplasmosis Uveal Diseases Uveitis Uveitis, Posterior

Age range

Up to 18 year

Study type

Interventional

Phase

Not applicable

Primary location

UniversityHospitalGrenoble

La Tronche, 38700, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorescein angiography

Other

Dilated fundus examination

Other

Toxoplasmosis serology

Biological

Anti-toxoplasmosis treatment

Drug

Anti-inflammatory treatments

Drug

Puncture in anterior chamber

Other

Primary outcomes

  1. ELISA tests

    Time frame: About an hour

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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: BIOLUVE

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jul 25, 2016
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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