Aspergillosis and Humoral Alveolar Immunity by Proteomics
ASPEOMIC
1 other identifier
observational
32
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2021
CompletedFirst Posted
Study publicly available on registry
January 28, 2021
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedJanuary 28, 2021
January 1, 2021
2 months
January 24, 2021
January 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Protein profile
Protein profiles of innate immunity in the pulmonary alveoli
at day 90
Study Arms (2)
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)
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
Interventions
Analysis of the protein content by proteomics of bronchoalveolar lavage
Eligibility Criteria
Patients with or without pulmonary aspergillosis for whom a bronchial fibroscopy with bronchoalveolar lavage is performed as part of their care path.
You may qualify if:
- Patient who are more than 18 years old
- 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).
- Patient who has given his consent.
- Patient who are more than 18 years old
- 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)
- Patient who has given his consent.
You may not qualify if:
- Pregnant woman
- Patient deprived of their rights
- Patient under tutorship or guardianship or under the protection of a conservator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2021
First Posted
January 28, 2021
Study Start
February 1, 2021
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
January 28, 2021
Record last verified: 2021-01