Japanese multicenter study of short- and long-term efficacy and safety of itraconazole in the treatment of chronic necrotizing pulmonary aspergillosis

UMIN ID: UMIN000001727

Registered date:23/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic Necrotizing Pulmonary Aspergillosis
• Date of first enrollment: 2008/06/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Itraconazole

Outcome(s)

• Primary Outcome: Clinical success rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Department of Clinical infectious Diseases, School of Medicine, Showa University
• Source(s) of Monetary Support: Japan Association of Health Service