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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
Sponsor:
Information provided by (Responsible Party):
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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
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 : January 2010
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016


Arm Intervention/treatment
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



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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
UniversityHospitalGrenoble
La Tronche, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Laurence Bouillet, Professor Grenoble Hospital University

Publications:
Derouin F, Bultel C, Roze S. (Coordination rédactionnelle). Toxoplasmose: état des connaissances et évaluation du risque lié à l'alimentation. Rapport du groupe de travail " Toxoplasma gondii " de l'Afssa. Coordination éditoriale : Thomann C & Ribeiro F. AFSSA Déc. 2005, pp318.

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02843438     History of Changes
Other Study ID Numbers: 38RC09.014
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Keywords provided by University Hospital, Grenoble:
Toxoplasmosis
Uveitis
Chorioretinitis
Infection
Additional relevant MeSH terms:
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Toxoplasmosis
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Coccidiosis
Protozoan Infections
Parasitic Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis
Anti-Inflammatory Agents