Aspergillus Fumigatus InfectionAspergillusOHNCT06532227
AspergillusOne-Health: Deciphering Azole Resistance in Aspergillus Fungi Using a One Health Approach
An observational study of Aspergillus Fumigatus Infection, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Aspergillus Fumigatus Infection
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Patient under guardianship or legal protection
- Patient of no fixed adress
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Nantes
Nantes, 44093
François-Xavier BLANC, 0240165710, xavier.blanc@chu-nantes.fr
About this study
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
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention excepted data collection
| Study group | Role | What they receive |
|---|---|---|
| Group control : patient without resistance | control patients with susceptible Aspergillus. Receives: Other: No intervention | |
| Group resistant : patient without resistance | Cases are patients with resistant Aspergillus Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Environmental risk factors
Identify the "macro" environmental risk factors for acquiring azole-resistant aspergillus.
Measured: 24 months
Secondary outcomes (2)
Describe the management and evolution of resistant
Clinical information from each additional patient visit and presence or absence of resistant Aspergillus in home samples.
Measured: 48 months
Risk factors
Identify individual risk factors linked to the immediate environment in the patient's home, drug management, between cases and matched controls, etc..
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspergillus Fumigatus InfectionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532227
- Sponsor's protocol ID
- RC23_0008
- Acronym
- AspergillusOH
- Status last verified
- Jun 2026
- First submitted
- 29 Jul 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AspergillusOne-Health: Deciphering Azole Resistance in Aspergillus Fungi Using a One Health Approach
- ClinicalTrials.gov ID
- NCT06532227
- Acronym / sponsor ID
- AspergillusOH / RC23_0008
- Conditions
- Aspergillus Fumigatus Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group control : patient without resistance | – | Other: No interventioncontrol patients with susceptible Aspergillus. |
| Group resistant : patient without resistance | – | Other: No interventionCases are patients with resistant Aspergillus |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patient under guardianship or legal protection
- Patient of no fixed adress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention excepted data collection | Other | Group control : patient without resistance, Group resistant : patient without resistance |
Primary outcome
Environmental risk factors
Time frame: 24 months
Identify the "macro" environmental risk factors for acquiring azole-resistant aspergillus.
2 secondary outcomes
Describe the management and evolution of resistant
Time frame: 48 months
Risk factors
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Related trials for Aspergillus Fumigatus Infection
RecruitingObservational study
PCR for Aspergillus Fumigatus in Blood and Bronchoalveolar Lavage Fluid for Monitoring Cases of Invasive Aspergillosis: What is Its Prognostic Value
Invasive Pulmonary Aspergillosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspergillus Fumigatus Infection, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François-Xavier Blanc, PUPH (0240165710, xavier.blanc@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Environmental risk factors (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.