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临床试验/NCT07054918
NCT07054918尚未招募不适用

Isolated Positive Toxoplasma Gondii PCR in Blood

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Demographic data: age

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Demographic data: age

时间窗: 1 year

expressed in years old

Demographic data: sex

时间窗: 1 year

choice between male/female

time between transplantation and positive T. gondii PCR

时间窗: 1 year

expressed in number of days

Underlying disease

时间窗: 1 year

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

Ongoing anti-T. gondii prophylaxis

时间窗: 1 year

molecule name

PCR Ct value at diagnosis

时间窗: 1 year

number of cycle threshold

Outcome 1 month after first positive PCR

时间窗: 1 year

death or alive

次要结局

未报告次要终点

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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