Unique ID issued by UMIN | UMIN000001727 |
---|---|
Receipt number | R000002081 |
Scientific Title | Japanese multicenter study of short- and long-term efficacy and safety of itraconazole in the treatment of chronic necrotizing pulmonary aspergillosis |
Date of disclosure of the study information | 2009/02/23 |
Last modified on | 2011/04/21 17:44:51 |
Japanese multicenter study of short- and long-term efficacy and safety of itraconazole in the treatment of chronic necrotizing pulmonary aspergillosis
Japanese multicenter study of itraconazole for chronic necrotizing pulmonary aspergillosis
Japanese multicenter study of short- and long-term efficacy and safety of itraconazole in the treatment of chronic necrotizing pulmonary aspergillosis
Japanese multicenter study of itraconazole for chronic necrotizing pulmonary aspergillosis
Japan |
Chronic Necrotizing Pulmonary Aspergillosis
Medicine in general | Pneumology | Infectious disease |
Others
NO
1) To verify short- and long-term efficacy and safety of itraconazole in the treatment of chronic necrotizing pulmonary aspergillosis
2) To measure the MIC of itraconazole against Aspergillus, and perform PK/PD analyses
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Clinical success rate
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Itraconazole
20 | years-old | <= |
Not applicable |
Male and Female
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
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
100
1st name | |
Middle name | |
Last name | Yoshihito Niki |
School of Medicine, Showa University
Clinical infectious Diseases
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555
1st name | |
Middle name | |
Last name | Koichiro Yoshida |
School of Medicine, Showa University
Clinical infectious Diseases
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555
Department of Clinical infectious Diseases, School of Medicine, Showa University
Japan Association of Health Service
Non profit foundation
Japan
NO
2009 | Year | 02 | Month | 23 | Day |
Unpublished
Completed
2008 | Year | 04 | Month | 14 | Day |
2008 | Year | 06 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2009 | Year | 02 | Month | 23 | Day |
2011 | Year | 04 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002081