Strongyloidiasis at CHRU Nancy: Evaluation of the Performance of Serological Tests and Disease-associated Characteristics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- serological result
研究概览
简要总结
Strongyloidiasis is a disease caused by a parasite belonging to the helminth phylum: Strongyloides stercoralis. This nematode is mainly found in warm and humid regions, which favor its survival and transmission to humans. The disease presents several clinical forms: symptomatic forms, which are characteristic and make diagnosis easier, but also asymptomatic forms, where the parasite remains dormant in the human body thanks to the immune system. The latter form is particularly dangerous in cases of immunosuppression (cancers, corticosteroid treatment) or during organ donation. Therefore, knowing the serological status of a patient who has lived in an endemic area is essential to prevent severe strongyloidiasis.
To mitigate this risk, a new recommendation (2023) regarding the serological screening of organ donors has been issued, specifically concerning strongyloidiasis serology. To meet this requirement, the CHRU Nancy laboratory implemented an ELISA serological technique for detecting immunoglobulins directed against the parasite (Strongyloides stercoralis). A call for tenders was launched in summer 2025, with three responses from different suppliers (Launch, Euroimmun, Bordier).
Over the past 15 months, 600 serological tests have been performed, including 60 positive and 20 borderline results. The question is whether these results represent true strongyloidiasis cases and to assess the diagnostic performance of the technique used, particularly its specificity and sensitivity.
Primary objective:
Evaluate the performance of the three ELISA serological techniques for diagnosing strongyloidiasis.
Secondary objectives:
Identify and assess the socio-demographic, clinical, biological, and epidemiological characteristics of patients with strongyloidiasis.
Evaluate compliance with recommendations by healthcare professionals when faced with a positive strongyloidiasis serology (recommendations: add microfilaria serology and initiate ivermectin treatment).
Identify the context in which strongyloidiasis serology is prescribed (diagnosis of digestive parasitosis, compliance with PMO/organ recipient recommendations, pre-immunosuppression workup, etc.).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with strongyloidiasis serology performed between January 2024 and June 2025
- •Whose serum tube residues are available in the biobank
- •Who have not objected to the reuse of their data for research purposes
排除标准
- •< 18 years old
结局指标
主要结局
serological result
时间窗: baseline
次要结局
未报告次要终点
研究者
Anne DEBOURGOGNE
PU-PH
Central Hospital, Nancy, France
