Invasive Fungal Disease Clinical Trial
— IMMUNOFILOfficial title:
Immunomonitoring of Mold Invasive Infections
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | March 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 at 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 Exclusion Criteria: - Lymphocyte count < 0.5 G/L - Bacterial infection in the last 14 days - Previous treatment with anti-PD1 antibodies |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Necker Enfants Malades | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immune checkpoint expression on T cells | 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 | Day 0, day 14, week 6 | |
Secondary | Aspergillus/Mucorales FLUOROSPOT | Qualitative and quantitative measure of specific T cells IFN-?/IL-2/IL-5/IL-17 production by FLUOROSPOT after antigenic stimulation in absence and presence of an anti-PD1 antibody in patients with invasive aspergillosis or mucormycosis | Day 0, week 6 | |
Secondary | T cell proliferation | T cell proliferation test after antigenic stimulation | Day 0, week 6 | |
Secondary | Immune checkpoint expression on monocytes | Percentage of circulating monocytes expressing immune checkpoint molecules | Day 0, day 14, week 6 |
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