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Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis (TREXO)

Primary Purpose

Toxoplasmosis Infection, Genotype II, Ocular Toxoplasmosis With Recurrences

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
seropositive for Toxoplasma gondii
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Toxoplasmosis Infection

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • seropositive for Toxoplasma gondii (for patient and parents)
  • Infection with genotype II (for patient and parents)
  • ocular toxoplasmosis recurrences >5 (patients only)

Exclusion Criteria:

  • Parents seronegative for T. gondii infection
  • Infection with others genotypes than type II

Sites / Locations

  • University Hospital, Strasbourg, france

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

seropositive for Toxoplasma gondii

Arm Description

Outcomes

Primary Outcome Measures

Highlighting of genetic mutations associated with the susceptibility to Toxoplasma gondii.severe eye recurrences. Mutation analysis will be done by exome sequencing of the subjects included in this study

Secondary Outcome Measures

Full Information

First Posted
August 8, 2016
Last Updated
August 31, 2021
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02863588
Brief Title
Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis
Acronym
TREXO
Official Title
Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulty
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
November 11, 2019 (Actual)
Study Completion Date
November 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Ocular toxoplasmosis (OT) is a major cause of visual impairment worldwide. OT is responsible for 30 to 50% of posterior uveitis. It is characterized by dormant infections that may reactivate without known reasons, causing severe irreversible visual loss. The overall recurrence rate of OT in Europe is greater than 80% for patients and may range from one episode to 11 episodes (1% of OT) in the most extreme cases. Current treatments do not reduce the risk of recurrences and the risk of toxoplasmosis recurrence cannot be predicted in these immunocompetent patients. These clinical and biological expression changes might be related to an individual genetic susceptibility of each patient. The advanced analysis of the entire genome now possible to consider the project.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxoplasmosis Infection, Genotype II, Ocular Toxoplasmosis With Recurrences

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
seropositive for Toxoplasma gondii
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
seropositive for Toxoplasma gondii
Intervention Description
blood sample
Primary Outcome Measure Information:
Title
Highlighting of genetic mutations associated with the susceptibility to Toxoplasma gondii.severe eye recurrences. Mutation analysis will be done by exome sequencing of the subjects included in this study
Time Frame
This analysis will be performed on a blood sample taken in patients included in the inclusion visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: seropositive for Toxoplasma gondii (for patient and parents) Infection with genotype II (for patient and parents) ocular toxoplasmosis recurrences >5 (patients only) Exclusion Criteria: Parents seronegative for T. gondii infection Infection with others genotypes than type II
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud SAUER, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Strasbourg, france
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis

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