Isolated Positive Toxoplasma Gondii PCR in Blood

NCT07054918 | Not Yet Recruiting

• 1 other identifier: 2025 NOURRISSON (TIPS)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Toxoplasmosis

Outcome Measures

Primary Outcomes (7)

• Demographic data: age

  expressed in years old

  1 year

• Demographic data: sex

  choice between male/female

  1 year

• time between transplantation and positive T. gondii PCR

  expressed in number of days

  1 year

• Underlying disease

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

  1 year

• Ongoing anti-T. gondii prophylaxis

  molecule name

  1 year

• PCR Ct value at diagnosis

  number of cycle threshold

  1 year

• Outcome 1 month after first positive PCR

  death or alive

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

-patient care at one of the participating centers

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Toxoplasmosis

Condition Hierarchy (Ancestors)

Coccidiosis; Protozoan Infections; Parasitic Diseases; Infections

Study Officials

• Céline NOURRISSON

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)