Chronic Respiratory DiseaseEPAR-APCNCT05064605
Pharmacological Evaluation of Antifungal in Chronic Pulmonary Aspergillosis
An observational study of Chronic Respiratory Disease and Chronic Pulmonary Aspergillosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
At present, pulmonary diffusion and target antifungal concentrations for APC in patients with sarcoidosis or chronic obstructive pulmonary disease (COPD) are unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Disease, Chronic Pulmonary Aspergillosis
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2021to 1 Oct 2024
- Phase
- Observational
- 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
Study population: patients with chronic respiratory diseases such as sarcoidosis or chronic obstructive pulmonary disease
Who may be able to join
- Patient over 18 years of age
- Diagnosis of PCA made according to the criteria of Denning et al. Eur Respir J. 2016
- Previously initiated or newly initiated azole antifungal therapy for chronic lung disease complicated by CPA.
- Informed patients who did not object to the use of their data.
Who cannot join
- Pregnant woman
- Co-medication affecting the pharmacokinetics of antifungal agents:
- Enzyme inducing therapy (rifampin, rifabutin, phenytoin, phenobarbital, efavirenz, nevirapine, etravirine, ritonavir in the case of voriconazole) Drugs that may inhibit the metabolism of antifungal drugs (ritonavir and cobicistat for itraconazole and isavuconazole)
- Patients under guardianship/guardianship
- Patients without social security coverage
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Avicenne
Bobigny, 93000
UZUNHAN Yurdagül, yurdagul.uzuhnan@aphp.fr
About this study
Official title: Pharmacological Evaluation of Antifungal Drugs in Respiratory Samples of Patiens With Chronic Pulmonary Aspergillosis
At present, pulmonary diffusion and target antifungal concentrations for APC in patients with sarcoidosis or chronic obstructive pulmonary disease (COPD) are unknown.
Read the detailed description
Knowledge of these elements is however an essential prerequisite for optimizing the dosages in these contexts. The main objective of the study is to quantify the diffusion of antifungals in the lower respiratory tract in patients treated for pulmonary aspergillosis in the context of underlying chronic respiratory disease. Determining this level of diffusion will make it possible to deduce the plasma concentrations to be achieved in patients and to identify the molecules with the best diffusion profile. The concentration of antifungals in the lungs will be measured from 3 types of samples:
- Sputum obtained by expectoration. These samples will make it possible to quantify the diffusion at the level of the upper and lower respiratory tree.
- Bronchial aspirations. These samples will make it possible to quantify the diffusion at the level of the deep respiratory tree.
- Bronchoalveolar lavage fluid, which will quantify the diffusion at the level of the deep respiratory tree and the ELF.
Blood samples will be taken simultaneously so as to determine the percentage of diffusion from the plasma to the lung.
All these samples will be taken as part of the standard care of patients, the lung samples having the main use of mycological monitoring, the blood samples having the main use of pharmacological and serological monitoring. Lung samples will also be taken routinely for pharmacological monitoring, in order to measure antifungal concentrations at the site of infection.
Mycological monitoring will consist of measuring the fungal load in the broncho-respiratory secretions as well as carrying out an antifongigram in the event of isolation of Aspergillus spp.
The possible association between plasma and pulmonary concentrations of antifungals on the one hand, and mycological and clinical markers of treatment efficacy on the other hand, will also be investigated. The mycological markers of efficacy will be the results of mycological monitoring (culture of broncho-respiratory secretions and aspergillus serology). The clinical markers will be the pulmonary imaging results obtained as part of the management of these patients. The identification of such combinations should allow target concentrations of antifungals to be defined and, where appropriate, antifungal dosage recommendations specific to the treatment of PCA in patients with chronic respiratory disease to be defined.
- Keywords
- Sarcoidosis, Chronic obstructive pulmonary disease, Chronic pulmonary aspergillosis
- Medical subject headings
- Sarcoidosis, Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of antifungal concentrations in lung samples/plasma samples depending on the type of lung sample (sputum, bronchial aspiration, bronchoalveolar lavage fluid)
Ratio of antifungal concentrations in lung samples/plasma samples depending on the type of lung sample
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Oct 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yurdagül Yuzunhan, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064605
- Sponsor's protocol ID
- APHP211257
- Acronym
- EPAR-APC
- Status last verified
- Jun 2022
- First submitted
- 22 Sep 2021
- Last updated
- 28 Jun 2022
- 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 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Evaluation of Antifungal Drugs in Respiratory Samples of Patiens With Chronic Pulmonary Aspergillosis
- ClinicalTrials.gov ID
- NCT05064605
- Acronym / sponsor ID
- EPAR-APC / APHP211257
- Keywords
- Sarcoidosis, Chronic obstructive pulmonary disease, Chronic pulmonary aspergillosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 1 Oct 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.
At present, pulmonary diffusion and target antifungal concentrations for APC in patients with sarcoidosis or chronic obstructive pulmonary disease (COPD) are unknown.
Detailed description
Knowledge of these elements is however an essential prerequisite for optimizing the dosages in these contexts. The main objective of the study is to quantify the diffusion of antifungals in the lower respiratory tract in patients treated for pulmonary aspergillosis in the context of underlying chronic respiratory disease. Determining this level of diffusion will make it possible to deduce the plasma concentrations to be achieved in patients and to identify the molecules with the best diffusion profile. The concentration of antifungals in the lungs will be measured from 3 types of samples:
- Sputum obtained by expectoration. These samples will make it possible to quantify the diffusion at the level of the upper and lower respiratory tree.
- Bronchial aspirations. These samples will make it possible to quantify the diffusion at the level of the deep respiratory tree.
- Bronchoalveolar lavage fluid, which will quantify the diffusion at the level of the deep respiratory tree and the ELF.
Blood samples will be taken simultaneously so as to determine the percentage of diffusion from the plasma to the lung.
All these samples will be taken as part of the standard care of patients, the lung samples having the main use of mycological monitoring, the blood samples having the main use of pharmacological and serological monitoring. Lung samples will also be taken routinely for pharmacological monitoring, in order to measure antifungal concentrations at the site of infection.
Mycological monitoring will consist of measuring the fungal load in the broncho-respiratory secretions as well as carrying out an antifongigram in the event of isolation of Aspergillus spp.
The possible association between plasma and pulmonary concentrations of antifungals on the one hand, and mycological and clinical markers of treatment efficacy on the other hand, will also be investigated. The mycological markers of efficacy will be the results of mycological monitoring (culture of broncho-respiratory secretions and aspergillus serology). The clinical markers will be the pulmonary imaging results obtained as part of the management of these patients. The identification of such combinations should allow target concentrations of antifungals to be defined and, where appropriate, antifungal dosage recommendations specific to the treatment of PCA in patients with chronic respiratory disease to be defined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic respiratory diseases such as sarcoidosis or chronic obstructive pulmonary disease
Key inclusion criteria (4 listed)
- Patient over 18 years of age
- Diagnosis of PCA made according to the criteria of Denning et al. Eur Respir J. 2016
- Previously initiated or newly initiated azole antifungal therapy for chronic lung disease complicated by CPA.
- Informed patients who did not object to the use of their data.
Key exclusion criteria (5 listed)
- Pregnant woman
- Co-medication affecting the pharmacokinetics of antifungal agents:
- Enzyme inducing therapy (rifampin, rifabutin, phenytoin, phenobarbital, efavirenz, nevirapine, etravirine, ritonavir in the case of voriconazole) Drugs that may inhibit the metabolism of antifungal drugs (ritonavir and cobicistat for itraconazole and isavuconazole)
- Patients under guardianship/guardianship
- Patients without social security coverage
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
Ratio of antifungal concentrations in lung samples/plasma samples depending on the type of lung sample (sputum, bronchial aspiration, bronchoalveolar lavage fluid)
Time frame: At 12 months
Ratio of antifungal concentrations in lung samples/plasma samples depending on the type of lung sample
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
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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.
Yurdagül Yuzunhan, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Chronic Respiratory Disease and Chronic Pulmonary Aspergillosis, run by Assistance Publique - Hôpitaux de Paris 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 5 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 28 Jun 2022. 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 Yurdagül Yuzunhan, MD PhD (+33148956467, yurdagul.yuzunhan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of antifungal concentrations in lung samples/plasma samples depending on the type of lung sample (sputum, bronchial aspiration, bronchoalveolar lavage fluid) (time frame: At 12 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 28 Jun 2022.