ClinicalTrials.gg
Not yet recruitingNCT07054918TIPSUpdated Jul 11, 2025

Isolated Positive Toxoplasma Gondii PCR in Blood

An observational study in Toxoplasmosis, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2025-07-11.

Sponsored by University Hospital, Clermont-Ferrand · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
100
Sex
All
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Study summary

Toxoplasmosis in immunocompromised patients is a serious, life-threatening condition that requires rapid, appropriate treatment. Diagnosis is based on PCR, notably on blood samples. Systematic blood screening is carried out for patients most at risk, to detect the disease at an early stage. Detection of parasite DNA in blood in asymptomatic patients is possible, in the absence of Toxoplasma multiplication. It has previously been proposed a distinction of two entities: toxoplasmosis disease (clinical, biological and imaging evidence of toxoplasmosis) and toxoplasmosis infection (positive PCR in the blood in the absence of clinical or radiological evidence, without progression to toxoplasmosis). Since the clinical signs of toxoplasmosis are often aspecific, a positive PCR may be the first warning result, making it difficult to determine whether the patient will progress to toxoplasmosis disease or toxoplasmosis infection.

In collaboration with the French National Reference Center for toxoplasmosis, we are proposing a retrospective multicenter study to identify possible clinical, biological or imaging criteria pointing to toxoplasmosis disease or toxoplasmosis infection as soon as the first T. gondii PCR result is positive in the blood.

02

Conditions studied

  • Toxoplasmosis

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03

In context

Toxoplasmosis

29 studies on the registry are indexed under Toxoplasmosis; 8 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 10 observational studies indexed under Toxoplasmosis.

Browse Toxoplasmosis studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

-patient care at one of the participating centers

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • T. gondii positive-PCR in blood during the study period: no symptoms of toxoplasmosis since the last systematic PCR negative in blood and no history of T. gondii positive-PCR in any biological matrix for 6 weeks.

Exclusion criteria

Exclusion Criteria:

  • pre-analytical or analytical error leading to a false-positive result
  • unknown toxoplasmosis immune status or non-immune subject
  • serology in favor of acute toxoplasmosis
  • congenital toxoplasmosis, ocular toxoplasmosis, toxoplasmosis in the context of /AIDS
  • patient opposition
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Demographic data: age

    expressed in years old

    Time frame: 1 year

  2. Demographic data: sex

    choice between male/female

    Time frame: 1 year

  3. time between transplantation and positive T. gondii PCR

    expressed in number of days

    Time frame: 1 year

  4. Underlying disease

    for example: acute leukemia, solid organ transplant, ...

    Time frame: 1 year

  5. Ongoing anti-T. gondii prophylaxis

    molecule name

    Time frame: 1 year

  6. PCR Ct value at diagnosis

    number of cycle threshold

    Time frame: 1 year

  7. Outcome 1 month after first positive PCR

    death or alive

    Time frame: 1 year

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2025; primary completion for Dec 2025, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2025
First posted
Jul 8, 2025
StartEst.
Sep 2025
Primary completionEst.
Dec 2025
CompletionEst.
Mar 2026
Last update
Jul 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07054918
Responsible party
Sponsor
First posted
Jul 8, 2025
Start date
Sep 2025 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Mar 2026 (estimated)
Last update
Jul 11, 2025

Study contacts

Lise LACLAUTRE
Contact
promo_interne_drci@chu-clermontferrand.fr
334.73.754.963
Céline NOURRISSON
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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