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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001727
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Clinical infectious Diseases, School of Medicine, Showa University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002081

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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