Immunomonitoring of Mold Invasive Infections

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Bacterial co-infection in the last 14 days

Previous treatment with anti-PD1 antibodies

Trial population

Tertiary care centers

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

20 Participants
are grouped into 1 trial group
Group A: Cohort of patients with mold invasive fungal infection

Trial outcomes

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

Time frame
Day 0, day 14, week 6

Secondary outcomes

1

Aspergillus/Mucorales FLUOROSPOT

Qualitative and quantitative measure of specific T cells IFN-γ/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

Time frame
Day 0, week 6
2

T cell proliferation

T cell proliferation test after antigenic stimulation

Time frame
Day 0, week 6
3

Immune checkpoint expression on monocytes

Percentage of circulating monocytes expressing immune checkpoint molecules

Time frame
Day 0, day 14, week 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator