Invasive Pulmonary AspergillosisBM-ASP-ICUNCT05138666
Non-invasive Tools to Diagnose Invasive Aspergillosis Infections in ICU Patients With COVID-19 and Other Conditions.
A study testing respiratory sample and blood sample in people with Invasive Pulmonary Aspergillosis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Invasive aspergillosis (IA) are difficult to diagnose in the ICU population, as the patients often do not present the conventional risks factors of immunocompromised patients (EORTC/MSG criteria). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Pulmonary Aspergillosis
- What is being tested?
- respiratory sample and blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2022to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- ICU adult patient (age > 18 years old at inclusion)
- Patient with respiratory distress (fever refractory to > 3 days of antibiotherapy, pleuritic chest pain, hemoptysis) or Patient with sign of infection on thoracic scan or Patient with positive culture for Aspergillus sp on any respiratory sample
- Informed consent signed by the patient or proxy
- Patient with health insurance
Who cannot join
- Minor patient (age < 18 years old at inclusion)
- Known risk of immunodepression as defined by EORTC/MSG:
- Recent history neutropenia (< 500 neutrophils/mm3 for > 10 days)
- Haematological malignancy
- Receipt of an allogenic stem cell transplant
- Receipt of a solid organ transplant
Show all 14Show fewer
- Prolonged use of corticosteroids (excluding among patients with allergic bronchopulmonary aspergillosis) at a therapeutic dose of ≥0·3 mg/kg corticosteroids for ≥3 weeks in the past 60 days
- Treatment with recognized T-cell immunosuppressant for more than 90 days (such as calcineurin inhibitors, TNF blockers, lymphocyte-specific monoclonal antibodies, and immunosuppressive nucleoside analogues)
- Treatment with recognized inhibitors of B-cell receptor pathway (e. g, ibrutinib), possibly BCL2 inhibitors (e. g, venetoclax)
- Inherited severe immunodeficiency (e. g, chronic granulomatous disease, STAT3 deficiency, or severe combined immunodeficiency)
- Acute graft-versus-host disease grade III or IV, involving the gut, lungs, or liver, that is refractory to first-line treatment with steroids
- Patient under legal protection (e. g, tutorship)
- Patients without health insurance
- Pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Besançon
Besançon
Laurence MILLON, PU-PH
About this study
Official title: Non-invasive Tools to Better Diagnose Invasive Aspergillosis Infections in ICU Patients With COVID-19 and Other Non-immunosuppressive Conditions.
Invasive aspergillosis (IA) are difficult to diagnose in the ICU population, as the patients often do not present the conventional risks factors of immunocompromised patients (EORTC/MSG criteria). In the ICU population, patients often present other risk factors, such as cirrhosis, COPD, influenza and currently SARS-Cov2. The clinicians are thus currently missing precise criteria to distinguish colonization from IA in these patients, while they need to decide if an antifungal treatment is necessary or not.
A new algorithm, entitled BM ASP ICU, based on investigators field experience and the scientific literature, which takes into account both EORTC/MSG criteria and a combination of fungal biomarkers, was proposed recently by Haman et al, Annals Intensive Care, 2021. Additional serological assays (immunoprecipitation and ELISA) showed since their interest, especially concerning SARS-Cov2 patients, a new population at risk of IA in the ICU, which emerged in the past months.
Read more
The present study aims at prospectively implementing the BM ASP ICU algorithm during two years in the routine practice of six ICU units distributed in general and teaching hospitals situated northeast of France. The BM ASP ICU algorithm would be completed by serological assays aiming at assessing a sensitization towards Aspergillus fumigatus.
The investigators plan to include 400 ICU patients at risk of IA; SARS-Cov2 patients will be part of the cohort. A weekly screening including culture of respiratory samples, galactomannan antigen, fungal qPCRS (targeting A. fumigatus), and A. fumigatus serology will be applied for all included patients.
The performance (sensitivity and specificity, likelihood ratios) of each fungal biomarkers, alone and in combination with others, will be assessed, for all patients, and also within subgroups of patients with specific risk factors (such as SARS-Cov2 for example).
These results should lead to solid understanding of which combination of tests is optimal to diagnose IA and thus to initiate appropriate antifungal treatment. the investigators hope that this study will result in improved survival rate of ICU patients with IA.
- Conditions
- Invasive Pulmonary Aspergillosis
- Being tested
- respiratory sample, blood sample
- Keywords
- ICU patients, Covid-19
- Medical subject headings
- Invasive Pulmonary Aspergillosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory sampleBiological
tracheal aspirate or sputum if the patient is not intubated
blood sampleBiological
Blood sampling drawn from an existing arterial line twice a week
| Study group | Role | What they receive |
|---|---|---|
| biological sample | Experimental | respiratory and blood sample Receives: Biological: respiratory sample; Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance indicators of the algorithm
sensitivity, specificity, positive and negative predictive values, and likelihood ratios.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start16 Sep 2022
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (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 Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 363 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Chrisptophe NAVELLOU, MD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138666
- Sponsor's protocol ID
- 2021/656
- Acronym
- BM-ASP-ICU
- Status last verified
- Apr 2023
- First submitted
- 17 Nov 2021
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Tools to Better Diagnose Invasive Aspergillosis Infections in ICU Patients With COVID-19 and Other Non-immunosuppressive Conditions.
- ClinicalTrials.gov ID
- NCT05138666
- Acronym / sponsor ID
- BM-ASP-ICU / 2021/656
- Conditions
- Invasive Pulmonary Aspergillosis
- Keywords
- ICU patients, Covid-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 363 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 1 Dec 2021 (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.
Invasive aspergillosis (IA) are difficult to diagnose in the ICU population, as the patients often do not present the conventional risks factors of immunocompromised patients (EORTC/MSG criteria). In the ICU population, patients often present other risk factors, such as cirrhosis, COPD, influenza and currently SARS-Cov2. The clinicians are thus currently missing precise criteria to distinguish colonization from IA in these patients, while they need to decide if an antifungal treatment is necessary or not.
A new algorithm, entitled BM ASP ICU, based on investigators field experience and the scientific literature, which takes into account both EORTC/MSG criteria and a combination of fungal biomarkers, was proposed recently by Haman et al, Annals Intensive Care, 2021. Additional serological assays (immunoprecipitation and ELISA) showed since their interest, especially concerning SARS-Cov2 patients, a new population at risk of IA in the ICU, which emerged in the past months.
The present study aims at prospectively implementing the BM ASP ICU algorithm during two years in the routine practice of six ICU units distributed in general and teaching hospitals situated northeast of France. The BM ASP ICU algorithm would be completed by serological assays aiming at assessing a sensitization towards Aspergillus fumigatus.
The investigators plan to include 400 ICU patients at risk of IA; SARS-Cov2 patients will be part of the cohort. A weekly screening including culture of respiratory samples, galactomannan antigen, fungal qPCRS (targeting A. fumigatus), and A. fumigatus serology will be applied for all included patients.
The performance (sensitivity and specificity, likelihood ratios) of each fungal biomarkers, alone and in combination with others, will be assessed, for all patients, and also within subgroups of patients with specific risk factors (such as SARS-Cov2 for example).
These results should lead to solid understanding of which combination of tests is optimal to diagnose IA and thus to initiate appropriate antifungal treatment. the investigators hope that this study will result in improved survival rate of ICU patients with IA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biological sample | Experimental | Biological: respiratory sample, Biological: blood samplerespiratory and blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICU adult patient (age > 18 years old at inclusion)
- Patient with respiratory distress (fever refractory to > 3 days of antibiotherapy, pleuritic chest pain, hemoptysis) or Patient with sign of infection on thoracic scan or Patient with positive culture for Aspergillus sp on any respiratory sample
- Informed consent signed by the patient or proxy
- Patient with health insurance
Key exclusion criteria (14 listed)
- Minor patient (age < 18 years old at inclusion)
- Known risk of immunodepression as defined by EORTC/MSG:
- Patient under legal protection (e. g, tutorship)
- Patients without health insurance
- Pregnancy
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 |
|---|---|---|
| respiratory sampletracheal aspirate or sputum if the patient is not intubated | Biological | biological sample |
| blood sampleBlood sampling drawn from an existing arterial line twice a week | Biological | biological sample |
Primary outcome
Performance indicators of the algorithm
Time frame: 90 days
sensitivity, specificity, positive and negative predictive values, and likelihood ratios.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jean-Chrisptophe NAVELLOU, MD principal investigator
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing respiratory sample and blood sample in people with Invasive Pulmonary Aspergillosis, run by Centre Hospitalier Universitaire de Besancon 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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 24 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurence MILLON, MD (0370632353, lmillon@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance indicators of the algorithm (time frame: 90 days). 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 Apr 2023.