CClinicalTrials.gg
Status unknownNCT04728763ASPEOMICUpdated Jan 28, 2021

Aspergillosis and Humoral Alveolar Immunity by Proteomics

An observational study in Aspergillus Fumigatus Infection, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-28.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
32
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Aspergillus Fumigatus Infection

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In context

Aspergillosis

201 studies on the registry are indexed under Aspergillosis; 22 are open to participants now.

This study's planned enrollment of 32 is below the median of 150 across 81 observational studies indexed under Aspergillosis.

Browse Aspergillosis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
32 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherProtein profile

    Analysis of the protein content by proteomics of bronchoalveolar lavage

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What researchers measure

Primary outcomes

  1. Protein profile

    Protein profiles of innate immunity in the pulmonary alveoli

    Time frame: at day 90

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04728763
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jan 28, 2021
Start date
Feb 2021 (estimated)
Primary completion
Apr 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
Jan 28, 2021

Study contacts

Stephane Bretagne, Pr
Contact
stephane.bretagne@aphp.fr
+33142499501
Matthieu Resche-Rigon, Pr
Contact
matthieu.resche-rigon@univ-paris-diderot.fr
+33142499742

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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