Ignite Creation Date:
2024-05-06 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05064605
Status:
UNKNOWN
Last Update Posted:
2022-06-28
First Post:
2021-09-22
Brief Title:
Pharmacological Evaluation of Antifungal in Chronic Pulmonary Aspergillosis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Pharmacological Evaluation of Antifungal Drugs in Respiratory Samples of Patiens With Chronic Pulmonary Aspergillosis
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPAR-APC
Brief Summary:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None