Strongyloidiasis at CHRU Nancy: Evaluation of the Performance of Serological Tests and Disease-associated Characteristics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-05

Study Completion Date

2025-11-15

Brief Summary

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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.).

Detailed Description

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Conditions

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Strongyloidiasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Strongyloides serology

serological test for Strongyloides antibody

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* \< 18 years old

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Anne DEBOURGOGNE

PU-PH

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHRU Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2025PI080

Identifier Type: -

Identifier Source: org_study_id