EPAR-APC: Pharmacological Evaluation of Antifungal in Chronic Pulmonary Aspergillosis

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT05064605
Collaborator
(none)
50
1
36
1.4

Study Details

Study Description

Brief Summary

At present, pulmonary diffusion and target antifungal concentrations for APC in patients with sarcoidosis or chronic obstructive pulmonary disease (COPD) are unknown.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pharmacological Evaluation of Antifungal Drugs in Respiratory Samples of Patiens With Chronic Pulmonary Aspergillosis
    Actual Study Start Date :
    Oct 1, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Oct 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Ratio of antifungal concentrations in lung samples/plasma samples depending on the type of lung sample (sputum, bronchial aspiration, bronchoalveolar lavage fluid) [At 12 months]

      Ratio of antifungal concentrations in lung samples/plasma samples depending on the type of lung sample

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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.

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Avicenne Bobigny France 93000

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Yurdagül Yuzunhan, MD, PhD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT05064605
    Other Study ID Numbers:
    • APHP211257
    First Posted:
    Oct 1, 2021
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 28, 2022