Immunomonitoring of Mold Invasive Infections

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Necker Enfants Malades
RECRUITING
Paris
Contact Information
Primary
Alexandra SERRIS, MD, PhD
alexandra.serris@aphp.fr
06 68 80 24 92
Backup
Gael PLASTOW, Project advisor
gael.plastow@aphp.fr
01 44 38 18 57
Time Frame
Start Date: 2025-07-28
Estimated Completion Date: 2027-07
Participants
Target number of participants: 20
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov