Immunomonitoring of Mold Invasive Infections

NCT06285188 | Recruiting

• 2 other identifiers: APHP2211742023-A01398-37
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Invasive Fungal Disease; Mold Invasive Fungal Infection: Aspergillus, Mucorales, Fusarium, Scedosporium

Keywords

Invasive fungal diseases,; adaptative immunity against filamentous fungi; immune checkpoint molecules; anti-PD1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Aspergillus/Mucorales FLUOROSPOT

  Day 0, week 6

• T cell proliferation

  Day 0, week 6

• Immune checkpoint expression on monocytes

  Day 0, day 14, week 6

Study Arms (1)

Cohort of patients with mold invasive fungal infection

Patients \>18 y, with a diagnosis of proven or probable mold invasive fungal infection (Aspergillus, Mucorales, Fusarium or Scedosporium), according to modified 2019 EORTC/MGS criteria, at diagnosis or at a refractory state after a first-line antifungal treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary care centers

You may qualify if:

• 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

You may not qualify if:

• Bacterial co-infection in the last 14 days
• Previous treatment with anti-PD1 antibodies

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker Enfants Malades

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Fanny LANTERNIER, MD, PhD

  APHP

  STUDY CHAIR

Central Study Contacts

Alexandra SERRIS, MD, PhD

CONTACT

06 68 80 24 92; alexandra.serris@aphp.fr

Gael PLASTOW, Project advisor

CONTACT

01 44 38 18 57; gael.plastow@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: July 28, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)