Isolated Positive Toxoplasma Gondii PCR in Blood

ConditionToxoplasmosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

-patient care at one of the participating centers

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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