Pharmacological Evaluation of Antifungal in Chronic Pulmonary Aspergillosis

NCT05064605 | Unknown

• 1 other identifier: APHP211257
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Respiratory Disease; Chronic Pulmonary Aspergillosis

Keywords

Sarcoidosis; Chronic obstructive pulmonary disease; Chronic pulmonary aspergillosis

Outcome Measures

Primary Outcomes (1)

• 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

  At 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with chronic respiratory diseases such as sarcoidosis or chronic obstructive pulmonary disease

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Avicenne

Bobigny, 93000, France

RECRUITING

MeSH Terms

Conditions

Sarcoidosis; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yurdagül Yuzunhan, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yurdagül Yuzunhan, MD PhD

CONTACT

+33148956467; yurdagul.yuzunhan@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2024
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

FR (1)