Actively Recruiting
Immunomonitoring of Mold Invasive Infections
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-20
20
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying mold invasive fungal infections, which can be deadly even with the best antifungal treatments. This research focuses on how immune checkpoint inhibitors, originally developed for cancer, might help restore the immune system's ability to fight these infections. The study aims to monitor the immune response, especially the markers on T cells, to find which patients might benefit from adding immunotherapy and the best time to start it. The study includes adult patients diagnosed with mold invasive fungal infections like aspergillosis, mucormycosis, fusariosis, or scedosporiosis, either newly diagnosed or not responding to standard antifungal treatment. Researchers will measure immune checkpoint markers on T cells and monocytes at enrollment, day 14, and week 6. For patients with aspergillosis or mucormycosis, they will also assess specific T cell functions, including cytokine production and proliferation, with and without an anti-PD1 antibody, at enrollment and week 6. Participants will undergo blood tests at these time points to evaluate their immune responses using flow cytometry and FLUOROSPOT assays. The study will correlate immune data with patients' underlying conditions, infection types, treatments, and outcomes. This detailed monitoring will help guide when and for whom immunotherapy might be added to antifungal treatment. The study is expected to continue until 2027, and participants will be followed closely throughout the study period.
CONDITIONS
Brief Title
Immunomonitoring of Mold Invasive Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Proven or probable mold invasive fungal infection (Aspergillus, Mucorales, Fusarium, or Scedosporium) according to modified 2019 EORTC/MGS criteria
- Diagnosis within 14 days or refractory state after first-line antifungal treatment
- For aspergillosis or mucormycosis, total lymphocyte count greater than 700/mm3 on last sample
- No opposition to participate in the research
- Affiliated or beneficiary of a social security system
You will not qualify if you...
- Bacterial co-infection within the last 14 days
- Previous treatment with anti-PD1 antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants with mold invasive fungal infections are observed to assess immune checkpoint expression and immune response over time.
3 visits at enrollment, day 14, and week 6
Trial Site Locations
Total: 1 location
1
Hôpital Necker Enfants Malades
Paris, France, 75015
Actively Recruiting
Research Team
A
Alexandra SERRIS, MD, PhD
G
Gael PLASTOW, Project advisor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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