UMIN-CTR Clinical Trial

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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