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NCT Number: NCT07054918

Isolated Positive Toxoplasma Gondii PCR in Blood

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.

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Key information

Conditions

Toxoplasmosis Coccidiosis Infections Parasitic Diseases Protozoan Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Demographic data: age

    Time frame: 1 year

    expressed in years old

  2. Demographic data: sex

    Time frame: 1 year

    choice between male/female

  3. time between transplantation and positive T. gondii PCR

    Time frame: 1 year

    expressed in number of days

  4. Underlying disease

    Time frame: 1 year

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

  5. Ongoing anti-T. gondii prophylaxis

    Time frame: 1 year

    molecule name

  6. PCR Ct value at diagnosis

    Time frame: 1 year

    number of cycle threshold

  7. Outcome 1 month after first positive PCR

    Time frame: 1 year

    death or alive

Study contacts

Contact information is provided by the study sponsor or research team.

Lise LACLAUTRE

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: TIPS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 8, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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