Chronic Necrotizing Pulmonary Aspergillosis
Conditions
Interventions
Itraconazole
Sponsors
Department of Clinical infectious Diseases, School of Medicine, Showa University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Inclusion starts with admission to hospital regardless of whether an inpatient or outpatient 2) Meeting diagnostic criteria for clinical diagnosis or definitive diagnosis for respiratory medicinal CNPA described in "2007 Guideline for the diagnosis and treatment of profound mycosis" 3) Able to be followed up for at least 12 weeks 4) If pretreated with an antifungal agent, its use must have been continued for at least 1 month, with no tendency toward clinical improvement (antifungal agents are not specified) 5) Written informed consent obtained
Exclusion criteria
Exclusion criteria: 1) Pregnant or potentially pregnant women, or lactating women 2) Patients with any underlying diseases considered to have a significant impact on the course of treatment in this clinical study such as progressive cancer, serious heart failure, or serious respiratory failure 3) Patients with a stable lesion restricted to one area of the lung and considered a candidate for surgical resection 4) Patients receiving drugs contraindicated with itraconazole 5) Patients with history of hypersensitivity to itraconazole 6) Presence or history of serious liver disease 7) Patients with severe renal impairment (creatinine clearance < 30 mL/min) 8) Patients for whom inclusion in this clinical study is considered potentially disadvantageous 9) Patients who had been previously included in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety 2) Isolation frequency (%) of each Aspergillus species through culture 3) MICs of antifungal agents against isolated Aspergillus strains 4) Correlation between MIC and clinical efficacy 5) Measurement of plasma concentration of itraconazole | — |
Countries
Japan
Contacts
Public ContactKoichiro Yoshida
School of Medicine, Showa University Clinical infectious Diseases
Outcome results
None listed