AspergillusOne-Health: Deciphering Azole Resistance in Aspergillus Fungi Using a One Health Approach (AspergillusOH)

May 22, 2025 updated by: Nantes University Hospital
During a two year prospective study onpatients from department's hospitals and centralized by the pneumology department Nantes CH,all respiratory clinical samples will be cultivated for Aspergillus isolation (2900Aspergillusisolates) as standard care. The azole susceptibility pattern of isolates will be determined to itraconazole, voriconazole by subculture on azole- enriched medium at 35°c as primary screen and resistance confirmed by EUCAST Reference metho.In parallel, the relevance of detecting resistance (TR34 and TR46) directly in culture-negative BAL respiratory samples by a qPCR method will be studied in an attempt to reach a greater exhaustiveness of the resistance phenomeno. In case of azole-resistant isolate,patient data such as the underlying disease,date and site of Aspergillus isolation,disease classification,previous azole drug exposure,and home and work geographic allocation,occupation of the patient will be collecte. For all other aspergillus occurrences, underlying disease, previous azole drug exposure,home and work location of the patient will be collected in an attempt to identify risk factor.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Prospective inclusion of patients sampled as part of their care in a pneumology department (Nantes University Hospital or CHD Vendée) who are carriers of aspergillus. Patients will be contacted by email or paper mail if a strain is isolated.

Only patients with resistant strains and susceptible patients matched to resistant strains for this study will also receive a home visit from the CMEI (except for patients living in institutions).

Description

Inclusion Criteria:

  • Patient over 18 years of age
  • Patient who has given his or her consent to participate in the study
  • Patient affiliated to a social security scheme
  • Patient with a respiratory sample taken between 2020 and 2023 for the retrospective cohort and from 2024 for the prospective cohort in which Aspergillus has been isolated
  • Patients living in the Loire Atlantique and Vendée regions

Exclusion Criteria:

  • Patient under guardianship or legal protection
  • Patient of no fixed adress

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group control : patient without resistance
control patients with susceptible Aspergillus.
Other: No intervention
No intervention excepted data collection
Group resistant : patient without resistance
Cases are patients with resistant Aspergillus
Other: No intervention
No intervention excepted data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Environmental risk factors
Time Frame: 24 months
Identify the "macro" environmental risk factors for acquiring azole-resistant aspergillus.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors
Time Frame: 48 months
Identify individual risk factors linked to the immediate environment in the patient's home, drug management, between cases and matched controls, etc..
48 months
Describe the management and evolution of resistant
Time Frame: 48 months
Clinical information from each additional patient visit and presence or absence of resistant Aspergillus in home samples.
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • RC23_0008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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