UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Japanese multicenter study of short- and long-term efficacy and safety of itraconazole in the treatment of chronic necrotizing pulmonary aspergillosis
Acronym
Japanese multicenter study of itraconazole for chronic necrotizing pulmonary aspergillosis
Scientific Title
Japanese multicenter study of short- and long-term efficacy and safety of itraconazole in the treatment of chronic necrotizing pulmonary aspergillosis
Scientific Title:Acronym
Japanese multicenter study of itraconazole for chronic necrotizing pulmonary aspergillosis
Region
| Japan |
Condition
Condition
Chronic Necrotizing Pulmonary Aspergillosis
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical success rate
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Itraconazole
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihito Niki |
Organization
School of Medicine, Showa University
Division name
Clinical infectious Diseases
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Yoshida |
Organization
School of Medicine, Showa University
Division name
Clinical infectious Diseases
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555
TEL
Homepage URL
Sponsor or person
Institute
Department of Clinical infectious Diseases, School of Medicine, Showa University
Institute
Department
Personal name
Funding Source
Organization
Japan Association of Health Service
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 23 | Day |
Last modified on
| 2011 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002081
