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Clinical Trials in France / NCT06285188
Recruiting Observational

Immunomonitoring of Mold Invasive Infections

NCT06285188 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2025-07-28
Last updated
2025-11-20

Condition(s) studied

Invasive Fungal DiseaseMold Invasive Fungal Infection: Aspergillus, Mucorales, Fusarium, Scedosporium

Study summary

Mold invasive infections are associated with an important mortality despite optimization of the antifungal treatment. In a few case reports, immune checkpoints inhibitors, initially developed for neoplastic diseases, have shown a potential beneficial effect in such devastating infections by restoring an efficient immune response. The investigators propose a longitudinal monitoring of the adaptative immune response, notably immune checkpoint expression on T cells, during mold invasive infections to help identify the patients who could benefit from the adjunction of immunotherapy and the optimal timing of such strategy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * Mold invasive fungal infection: Aspergillus, Mucorales, Fusarium, Scedosporium * Proven or probable according to 2019 EORTC/MGS criteria modified by the adjunction of diabetes mellitus in the host criteria and Mucorales PCR in the microbiological criteria * Within 14 days of IFD diagnosis or * a refractory state defined by the 2009 MGS/EORT failure criteria (clinical, radiological, or microbiological failure) of a first-line antifungal treatment leading to a change of therapy by the attending physician of the patient * Patients with aspergillosis or mucormycosis for whom ELISPOTs are developed: Total lymphocyte count \> 700/mm3 on the last sample taken * No opposition to participate to the research * Affiliated or beneficiary of social security system Exclusion Criteria: * Bacterial co-infection in the last 14 days * Previous treatment with anti-PD1 antibodies

Primary outcome measure(s)

  • Immune checkpoint expression on T cells — Day 0, day 14, week 6
    percentage of circulating T cells expressing immune checkpoint molecules as well as the intracellular transcription factor TCF1 and mean fluorescence intensity (MFI) of this expression in each cell sub-population

Trial sites (1)

FacilityCityRegionStatus
Hôpital Necker Enfants Malades Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06285188 on ClinicalTrials.gov ↗ ← All trials in France