Immune monitoring during invasive mold infections.
Official title: Immunomonitoring of Mold Invasive Infections
Run by Assistance Publique - Hôpitaux de Paris · NCT06285188 · Data updated 2026-11-12
This project will test whether tracking T-cell immune checkpoints can identify adults with invasive mold infections who might benefit from adding immunotherapy to antifungal treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | July 28, 2025 |
| Main results expected | April 2027 |
| Study ends | July 2027 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT06285188 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with proven or probable invasive mold infections (Aspergillus, Mucorales, Fusarium, Scedosporium) enrolled within 14 days of diagnosis or with documented refractory disease, who meet lab criteria for specific assays (for example total lymphocytes >700/mm3 for ELISPOT) and have not previously received anti‑PD1 therapy.
✕Probably not a fit
Patients with recent bacterial co‑infection, prior anti‑PD1 treatment, severe lymphopenia that precludes immune testing, or those unable to attend the Paris site are unlikely to benefit from or be eligible for this monitoring approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a longitudinal observational project that follows adults with proven or probable invasive mold infections (Aspergillus, Mucorales, Fusarium, Scedosporium) to characterize adaptive immune responses over time. Investigators will measure immune checkpoint expression on T cells (for example PD‑1 and CTLA‑4), perform functional assays such as ELISPOT for selected patients, and correlate immune markers with clinical course and antifungal response. Patients are eligible if enrolled within 14 days of diagnosis or if they have refractory disease requiring a change in antifungal therapy, and selected assays require a minimum lymphocyte count. No experimental treatments are assigned; standard antifungal care continues while samples are collected to identify signals that could guide adjunct immunotherapy timing.
Why it matters
Potential benefit: If successful, this approach could help clinicians identify which patients with invasive mold infections might benefit from adding immune checkpoint–targeted immunotherapy and determine the best timing for such treatment.
How similar studies have gone: A few case reports and animal studies suggest immune checkpoint blockade can help in severe fungal infections and prior cytokine (IFNγ) adjuncts showed partial success, but robust clinical evidence for checkpoint blockade in invasive fungal disease is currently limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hôpital Necker Enfants Malades
Paris, France Recruiting
Study contacts
- Study coordinator: Alexandra SERRIS, MD, PhD
- Email: alexandra.serris@aphp.fr
- Phone: 06 68 80 24 92
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.