Japanese multicenter study of short- and long-term efficacy and safety of itraconazole in the treatment of chronic necrotizing pulmonary aspergillosis
- Conditions
- Chronic Necrotizing Pulmonary Aspergillosis
- Registration Number
- JPRN-UMIN000001727
- Lead Sponsor
- Department of Clinical infectious Diseases, School of Medicine, Showa University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical success rate
- Secondary Outcome Measures
Name Time Method 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