Congenital ToxoplasmosisPhase 3TOSCANENCT01202500
Assessment of Two Therapeutic Strategies in the Treatment of Children With Congenital Toxoplasmosis
A Phase 3 study testing reducing treatment to 3 months and registered length of treatment in people with Congenital Toxoplasmosis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Toxoplasmosis is a benign disease in healthy adults, but can be serious in the case of contamination during pregnancy: the parasite can pass through the placental barrier and infect the foetus. Read more about this study
- Who is it for?
- Ages 3 to 6 months
- Conditions the study is for
- Congenital Toxoplasmosis
- What is being tested?
- reducing treatment to 3 months and registered length of treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2010to 7 Apr 2022
- Phase
- Phase 3
- 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 3 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children meeting the following criteria can be included:
- Non-severe congenital toxoplasmosis diagnosed in utero or in the first 3 months of life, whether or not in utero treatment was given
- Treated for 3 months with pyrimethamine combined with sulfamides.
- age from 3 to 6 months (> 2 months and < 7 months)
- Diagnostic criteria for congenital toxoplasmosis:
- antenatal period: positive Polymerase Chain Reaction (PCR) on the amniotic fluid or positive mouse inoculation for the amniotic fluid
Show all 9Show fewer
- postnatal period: presence of specific Immunoglobuline M (IgM) and/or Immunoglobuline A (IgA), positive Western Blot Chemistry (WBC), increase in Immunoglobuline G (IgG).
- Severe congenital toxoplasmosis is defined by the presence at birth of at least one of the following signs: > or egal 3 cerebral calcifications, hydrocephaly, microcephaly, convulsions, microphtalmy.
- Informed consent must be provided by both parents.
Who cannot join
- Children with the following cannot be included:
- a severe form of congenital toxoplasmosis
- inflammatory retinal disease at inclusion or in whom the treatment is contra-indicated (history of hypersensitivity to one of the components, severe renal or hepatic insufficiency, a history of hepatitis linked to treatment with Fansidar®).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre, Randomised Study to Determine the Relative Efficacy of Two Therapeutic Strategies in the Treatment of Children With Congenital Toxoplasmosis
Toxoplasmosis is a benign disease in healthy adults, but can be serious in the case of contamination during pregnancy: the parasite can pass through the placental barrier and infect the foetus. The severity of congenital infection varies, but in France, where maternal seroconversions during pregnancy are treated, the manifestations of the disease are often infraclinical at birth and only appear during the first years of life in the form of retinochoroiditis. In order to prevent long-term sequellae, children with confirmed congenital toxoplasmosis (TC) are treated with pyrimethamine combined with either sulfadiazine or sulfadoxine (Fansidar®). The relative efficacy of these two combinations has not yet been evaluated. Moreover, there is no consensus about the duration of the treatment, which varies, in France, from 12 to 24 months depending on the centre. Compared with the duration of parasitaemia in non-treated children, which can persist for up to 4 weeks, these treatments are very long. They are also far longer than the 3 months of treatment, which is in accordance with the World Health Organization (WHO) recommendations, given in Denmark to infants identified as being infected with the parasite during neonatal screening. A one-year treatment was developed in the United States, but it mainly concerns only symptomatic children, given the absence of generalised screening in the United States of America (USA). We have no arguments to justify the use of treatments lasting one year or more in children with asymptomatic or mildly-symptomatic TC. As these treatments carry certain risks, which may be severe, notably with regard to haematological or skin conditions, they have to be supervised closely with biological tests, which adds further constraints for both the children and their parents and increases the cost to health care systems.
- Conditions
- Congenital Toxoplasmosis
- Being tested
- reducing treatment to 3 months, registered length of treatment
- Medical subject headings
- Toxoplasmosis, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reducing treatment to 3 monthsProcedure or surgery
The treatment will be stopped after 3 months
registered length of treatmentProcedure or surgery
The treatment procedure will follow the actual recommandation
| Study group | Role | What they receive |
|---|---|---|
| 12 months | Other | Not described Receives: Procedure: registered length of treatment |
| 3 months | Experimental | Not described Receives: Procedure: reducing treatment to 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
episode of retinochoroiditis
Time to the onset of a first episode of retinochoroiditis in the two years of the study (or the onset of a new episode in a child known to already have had at least one lesion), evaluated on a fundus examination using RetCam®.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study start28 Jul 2010
- Primary completion26 Jan 2017
- Study completion7 Apr 2022
Why it stopped: Fansidar marketing discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital ToxoplasmosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine BINQUET, MD, Study director, CHU Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202500
- Sponsor's protocol ID
- 2009-016528-30
- Other IDs
- 2009
- Acronym
- TOSCANE
- Status last verified
- Feb 2024
- First submitted
- 15 Sep 2010
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomised Study to Determine the Relative Efficacy of Two Therapeutic Strategies in the Treatment of Children With Congenital Toxoplasmosis
- ClinicalTrials.gov ID
- NCT01202500
- Acronym / sponsor ID
- TOSCANE / 2009-016528-30
- Conditions
- Congenital Toxoplasmosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Fansidar marketing discontinued
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 28 Jul 2010 (actual)
- Primary completion
- 26 Jan 2017 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 16 Sep 2010 (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.
Toxoplasmosis is a benign disease in healthy adults, but can be serious in the case of contamination during pregnancy: the parasite can pass through the placental barrier and infect the foetus. The severity of congenital infection varies, but in France, where maternal seroconversions during pregnancy are treated, the manifestations of the disease are often infraclinical at birth and only appear during the first years of life in the form of retinochoroiditis. In order to prevent long-term sequellae, children with confirmed congenital toxoplasmosis (TC) are treated with pyrimethamine combined with either sulfadiazine or sulfadoxine (Fansidar®). The relative efficacy of these two combinations has not yet been evaluated. Moreover, there is no consensus about the duration of the treatment, which varies, in France, from 12 to 24 months depending on the centre. Compared with the duration of parasitaemia in non-treated children, which can persist for up to 4 weeks, these treatments are very long. They are also far longer than the 3 months of treatment, which is in accordance with the World Health Organization (WHO) recommendations, given in Denmark to infants identified as being infected with the parasite during neonatal screening. A one-year treatment was developed in the United States, but it mainly concerns only symptomatic children, given the absence of generalised screening in the United States of America (USA). We have no arguments to justify the use of treatments lasting one year or more in children with asymptomatic or mildly-symptomatic TC. As these treatments carry certain risks, which may be severe, notably with regard to haematological or skin conditions, they have to be supervised closely with biological tests, which adds further constraints for both the children and their parents and increases the cost to health care systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 months | Other | Procedure: registered length of treatment |
| 3 months | Experimental | Procedure: reducing treatment to 3 months |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Non-severe congenital toxoplasmosis diagnosed in utero or in the first 3 months of life, whether or not in utero treatment was given
- Treated for 3 months with pyrimethamine combined with sulfamides.
- age from 3 to 6 months (> 2 months and < 7 months)
- antenatal period: positive Polymerase Chain Reaction (PCR) on the amniotic fluid or positive mouse inoculation for the amniotic fluid
- postnatal period: presence of specific Immunoglobuline M (IgM) and/or Immunoglobuline A (IgA), positive Western Blot Chemistry (WBC), increase in Immunoglobuline G (IgG).
Key exclusion criteria (3 listed)
- a severe form of congenital toxoplasmosis
- inflammatory retinal disease at inclusion or in whom the treatment is contra-indicated (history of hypersensitivity to one of the components, severe renal or hepatic insufficiency, a history of hepatitis linked to treatment with Fansidar®).
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 |
|---|---|---|
| reducing treatment to 3 monthsThe treatment will be stopped after 3 months | Procedure or surgery | 3 months |
| registered length of treatmentThe treatment procedure will follow the actual recommandation | Procedure or surgery | 12 months |
Primary outcome
episode of retinochoroiditis
Time frame: 2 years
Time to the onset of a first episode of retinochoroiditis in the two years of the study (or the onset of a new episode in a child known to already have had at least one lesion), evaluated on a fundus examination using RetCam®.
Results and safety
The study was stopped early (reason given: Fansidar marketing discontinued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
Related trials for Congenital Toxoplasmosis
RecruitingPhase 4
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
Toxoplasmosis
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.
Christine BINQUET, MD study director
CHU Dijon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing reducing treatment to 3 months and registered length of treatment in people with Congenital Toxoplasmosis, run by Centre Hospitalier Universitaire Dijon 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 9 inclusion and 3 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 22 Feb 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Fansidar marketing discontinued). 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?
episode of retinochoroiditis (time frame: 2 years). 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 22 Feb 2024.