Isolated Positive Toxoplasma Gondii PCR in Blood
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
- 否
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
