Pharmacological Evaluation of Antifungal in Chronic Pulmonary Aspergillosis (EPAR-APC)

  • STATUS
    Recruiting
  • End date
    Oct 1, 2024
  • participants needed
    50
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 11 July 2022

Summary

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

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.

Details
Condition Chronic Respiratory Disease, Chronic Pulmonary Aspergillosis
Clinical Study IdentifierNCT05064605
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on11 July 2022

Eligibility

Yes No Not Sure

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
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