Invasive Pulmonary AspergillosisASPNCT07313527
PCR for Aspergillus Fumigatus in Blood and Bronchoalveolar Lavage Fluid for Monitoring Cases of Invasive Aspergillosis: What is Its Prognostic Value
An observational study of Invasive Pulmonary Aspergillosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Aspergillus fumigatus PCR is currently used in conjunction with serum galactomannan to support the diagnosis of invasive aspergillosis or for monitoring at-risk patients not receiving antifungal prophylaxis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Pulmonary Aspergillosis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2025to Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major patient with positive Aspergillus fumigatus PCR on serum or bronchoalveolar lavage fluid at diagnosis, performed at the Strasbourg University Hospital between January 1, 2017, and December 31, 2024.
Who may be able to join
- Patients aged 18 years or older
- Positive Aspergillus fumigatus PCR on serum or bronchoalveolar lavage fluid at diagnosis, performed at the Strasbourg University Hospital between January 1, 2017, and December 31, 2024.
Who cannot join
- No subsequent Aspergillus fumigatus PCR (>24h)
- No diagnosis of probable or proven invasive aspergillosis (EORTC/MSGERC 2020 criteria)
- Effective antifungal treatment against Aspergillus initiated before the first PCR
- Death <72h after starting antifungal treatment
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, 1 recruiting
- Recruiting
Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Strasbourg, 67091
Baptiste Hoellinger, MD, 33 3 69 55 05 45, baptiste.hoellinger@chru-strasbourg.fr
Baptiste Hoellinger, MD
About this study
Aspergillus fumigatus PCR is currently used in conjunction with serum galactomannan to support the diagnosis of invasive aspergillosis or for monitoring at-risk patients not receiving antifungal prophylaxis. A positive result and a high titer are thought to be associated with the advanced stage of the disease and the fungal load. However, there is limited data on this subject, and no study has primarily focused on the variation of PCR levels during treatment and its potential correlation with treatment efficacy.
- Conditions
- Invasive Pulmonary Aspergillosis
- Keywords
- Invasive Pulmonary Aspergillosis, Aspergillus fumigatus PCR, Bronchoalveolar lavage fluid
- Medical subject headings
- Invasive Pulmonary Aspergillosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Death rate at day 30 in patients with a positive follow-up PCR (blood or bronchoalveolar lavage)
Death rate at day 30 in patients with a positive follow-up PCR (blood or bronchoalveolar lavage) after the start of treatment
Measured: Day 30 post-antifungal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start17 Mar 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Pulmonary AspergillosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313527
- Sponsor's protocol ID
- 9615
- Acronym
- ASP
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 2 Jan 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCR for Aspergillus Fumigatus in Blood and Bronchoalveolar Lavage Fluid for Monitoring Cases of Invasive Aspergillosis: What is Its Prognostic Value
- ClinicalTrials.gov ID
- NCT07313527
- Acronym / sponsor ID
- ASP / 9615
- Conditions
- Invasive Pulmonary Aspergillosis
- Keywords
- Invasive Pulmonary Aspergillosis, Aspergillus fumigatus PCR, Bronchoalveolar lavage fluid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 2 Jan 2026 (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.
Aspergillus fumigatus PCR is currently used in conjunction with serum galactomannan to support the diagnosis of invasive aspergillosis or for monitoring at-risk patients not receiving antifungal prophylaxis. A positive result and a high titer are thought to be associated with the advanced stage of the disease and the fungal load. However, there is limited data on this subject, and no study has primarily focused on the variation of PCR levels during treatment and its potential correlation with treatment efficacy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patient with positive Aspergillus fumigatus PCR on serum or bronchoalveolar lavage fluid at diagnosis, performed at the Strasbourg University Hospital between January 1, 2017, and December 31, 2024.
Key inclusion criteria (2 listed)
- Patients aged 18 years or older
- Positive Aspergillus fumigatus PCR on serum or bronchoalveolar lavage fluid at diagnosis, performed at the Strasbourg University Hospital between January 1, 2017, and December 31, 2024.
Key exclusion criteria (4 listed)
- No subsequent Aspergillus fumigatus PCR (>24h)
- No diagnosis of probable or proven invasive aspergillosis (EORTC/MSGERC 2020 criteria)
- Effective antifungal treatment against Aspergillus initiated before the first PCR
- Death <72h after starting antifungal treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death rate at day 30 in patients with a positive follow-up PCR (blood or bronchoalveolar lavage)
Time frame: Day 30 post-antifungal treatment
Death rate at day 30 in patients with a positive follow-up PCR (blood or bronchoalveolar lavage) after the start of treatment
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 2 Jan 2026.
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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 Invasive Pulmonary Aspergillosis, run by University Hospital, Strasbourg, France 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Jan 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 baptiste Hoellinger, MD (33 3 69 55 05 45, baptiste.hoellinger@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death rate at day 30 in patients with a positive follow-up PCR (blood or bronchoalveolar lavage) (time frame: Day 30 post-antifungal treatment). 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 2 Jan 2026.