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

NCT06532227 | Not Yet Recruiting

• 1 other identifier: RC23_0008
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Aspergillus Fumigatus Infection

Outcome Measures

Primary Outcomes (1)

• Environmental risk factors

  Identify the "macro" environmental risk factors for acquiring azole-resistant aspergillus.

  24 months

Secondary Outcomes (2)

• Describe the management and evolution of resistant

  48 months

• Risk factors

  48 months

Study Arms (2)

Group control : patient without resistance

control patients with susceptible Aspergillus.

Other: No intervention

Group resistant : patient without resistance

Cases are patients with resistant Aspergillus

Other: No intervention

Interventions

No intervention OTHER

No intervention excepted data collection

Group control : patient without resistance; Group resistant : patient without resistance

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Central Study Contacts

François-Xavier Blanc, PUPH

CONTACT

0240165710; xavier.blanc@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 23, 2025

Record last verified: 2025-05