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Isolated Positive Toxoplasma Gondii PCR in Blood

Isolated Positive Toxoplasma Gondii PCR in Blood

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07054918
Acronym
TIPS
Enrollment
100
Registered
2025-07-08
Start date
2025-09-30
Completion date
2026-03-31
Last updated
2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Toxoplasmosis

Brief 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.

Interventions

None listed

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

* 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 HIV/AIDS * patient opposition

Design outcomes

Primary

MeasureTime frameDescription
Demographic data: age1 yearexpressed in years old
Demographic data: sex1 yearchoice between male/female
time between transplantation and positive T. gondii PCR1 yearexpressed in number of days
Underlying disease1 yearfor example: acute leukemia, solid organ transplant, ...
Ongoing anti-T. gondii prophylaxis1 yearmolecule name
PCR Ct value at diagnosis1 yearnumber of cycle threshold
Outcome 1 month after first positive PCR1 yeardeath or alive

Countries

France

Contacts

Primary ContactLise LACLAUTRE
promo_interne_drci@chu-clermontferrand.fr334.73.754.963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026