Aspergillosis and Humoral Alveolar Immunity by Proteomics (ASPEOMIC)

Aspergillus fumigatus is the most common opportunistic mold found in lung fungal infections in humans. Aspergillus is the cause of invasive pulmonary aspergillosis with a poor prognosis in immunocompromised patients and the chronic pulmonary aspergillosis which affects 3 million patients worldwide, with underlying pulmonary pathologies such as tuberculosis and its sequelae. The medicinal means to fight against these different forms are limited and not very effective. In addition, the emergence of resistance makes the search for new therapeutic strategies of major importance.

The interaction between the fungal spore and our innate immune system is the first step leading to infection.

The innate immune system is made up of cellular immunity and humoral immunity. While the first is well described, the second, consisting of soluble mediators, is essential for anti-aspergillus immunity but relatively little studied. The study of soluble mediators present in the alveolar fluid interacting directly with the Aspergillus spore would make it possible to analyze the first stages of infection. The analysis of the proteome present in the bronchoalveolar lavage of uninfected patients, suffering from various forms of aspergillosis and suffering from other types of infections would make it possible to highlight the essential and specific components of anti- immunity aspergillary.

The objective of this study is to analyze the protein profiles of innate immunity in the pulmonary alveoli in the absence or presence of Aspergillus or non-fungal infection in order to highlight the soluble mediators of the more specific immunity of the Aspergillosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Aspergillus Fumigatus Infection
• Intervention / Treatment: Other: Protein profile

• Study Type: Observational
• Enrollment (Anticipated): 32

Contacts and Locations

• Study Contact: Name: Stephane Bretagne, Pr; Phone Number: +33142499501; Email: stephane.bretagne@aphp.fr
• Study Contact Backup: Name: Matthieu Resche-Rigon, Pr; Phone Number: +33142499742; Email: matthieu.resche-rigon@univ-paris-diderot.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with or without pulmonary aspergillosis for whom a bronchial fibroscopy with bronchoalveolar lavage is performed as part of their care path.

Description

Inclusion Criteria for the case group (IPA / CPA): :

1. Patient who are more than 18 years old
2. Patients for whom bronchial endoscopy with BAL is performed as part of an exploration of IPA or CPA in current care. Probable or proven invasive pulmonary aspergillosis according to the criteria of the EORTC (2019).
3. Patient who has given his consent.

Inclusion Criteria In the control group :

1. Patient who are more than 18 years old
2. Patients for whom bronchial endoscopy with BAL is performed as part of an exploration of diffuse interstitial lung disease or a lower respiratory infection other than Aspergillus in routine care. Chronic pulmonary aspergillosis according to the criteria of ESCMID / ERS (2016)
3. Patient who has given his consent.

Exclusion Criteria for the case and the control group:

1. Pregnant woman
2. Patient deprived of their rights
3. Patient under tutorship or guardianship or under the protection of a conservator

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Patients for whom bronchial endoscopy with BAL is performed as part of an exploration of invasive pulmonary aspergillosis (IPA) or Chronic pulmonary aspergillosis (CPA) in current care : Probable or proven invasive pulmonary aspergillosis according to the criteria of the EORTC (2019) or; Chronic pulmonary aspergillosis according to the criteria of ESCMID / ERS (2016)	Other: Protein profile; Analysis of the protein content by proteomics of bronchoalveolar lavage
Control Group; Patients for whom bronchial endoscopy with BAL is performed as part of an exploration of diffuse interstitial lung disease or a lower respiratory infection other than Aspergillus in routine care	Other: Protein profile; Analysis of the protein content by proteomics of bronchoalveolar lavage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein profile	Protein profiles of innate immunity in the pulmonary alveoli	at day 90

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 24, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Aspergillosis
• Other Study ID Numbers: APHP201003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No