Toxoplasmosis InfectionTREXONCT02863588
Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis
A study testing seropositive for Toxoplasma gondii in people with Toxoplasmosis Infection and Genotype II, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Toxoplasmosis Infection, Genotype II, Ocular Toxoplasmosis With Recurrences
- What is being tested?
- seropositive for Toxoplasma gondii
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2017to 11 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- seropositive for Toxoplasma gondii (for patient and parents)
- Infection with genotype II (for patient and parents)
- ocular toxoplasmosis recurrences >5 (patients only)
Who cannot join
- Parents seronegative for T. gondii infection
- Infection with others genotypes than type II
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- seropositive for Toxoplasma gondii
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seropositive for Toxoplasma gondiiBiological
blood sample
| Study group | Role | What they receive |
|---|---|---|
| seropositive for Toxoplasma gondii | Experimental | Not described Receives: Biological: seropositive for Toxoplasma gondii |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: This analysis will be performed on a blood sample taken in patients included in the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start30 Mar 2017
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Why it stopped: recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxoplasmosis InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud SAUER, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863588
- Sponsor's protocol ID
- 6433
- Acronym
- TREXO
- Status last verified
- Aug 2021
- First submitted
- 8 Aug 2016
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis
- ClinicalTrials.gov ID
- NCT02863588
- Acronym / sponsor ID
- TREXO / 6433
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulty
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| seropositive for Toxoplasma gondii | Experimental | Biological: seropositive for Toxoplasma gondii |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- seropositive for Toxoplasma gondii (for patient and parents)
- Infection with genotype II (for patient and parents)
- ocular toxoplasmosis recurrences >5 (patients only)
Key exclusion criteria (2 listed)
- Parents seronegative for T. gondii infection
- Infection with others genotypes than type II
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| seropositive for Toxoplasma gondiiblood sample | Biological | seropositive for Toxoplasma gondii |
Primary outcome
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
Results and safety
The study was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud SAUER, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing seropositive for Toxoplasma gondii in people with Toxoplasmosis Infection and Genotype II, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.