NCT04728763

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Status
unknown

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 24, 2021

Last Update Submit

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)

Other: Protein profile

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

Interventions

Analysis of the protein content by proteomics of bronchoalveolar lavage

CasesControl Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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