UMIN-CTR Clinical Trial

Basic information
Public title	Clinical efficacy, saftey and pharmacodynamics of antifungal agents on chronic pulmonary mycosis
Acronym	Clinical efficacy and of antifungal agents on pulmonary mycosis
Scientific Title	Clinical efficacy, saftey and pharmacodynamics of antifungal agents on chronic pulmonary mycosis
Scientific Title:Acronym	Clinical efficacy and of antifungal agents on pulmonary mycosis
Region	Japan

Condition
Condition	chronic pulmonary diseases chronic pulmonary mycosis
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the clnical efficacy and safety of the antifungal agents on chnoric pulmonary mycosis in chronic respiratory diseases
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	clnical efficacy and safety of the antifungal agents on chnoric pulmonary mycosis
Key secondary outcomes	Serum and sputum concentrations of antifungal agents

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Liposomal Amphotericin B 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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Hospitalized patients with chronic pulmonary mycosis 2) Patients with chronic respiratory diseases
Key exclusion criteria	1) Patients under treatment of radiotherapy and immunosuppressant at present 2) Patients who have serious acute diseases obviously
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shinji Middle name Last name Teramoto
Organization	National Hospital Organization, Tokyo National Hospital
Division name	Department of Pulmonary Medicine
Zip code	204-8585
Address	3-1-1 Takeoka, Kiyose, Tokyo, Japan
TEL	+81424912111
Email	shinjit-tky@umin.ac.jp

Public contact
Name of contact person	1st name Shinji Middle name Last name Teramoto
Organization	National Hospital Organization, Tokyo National Hospital
Division name	Department of Pulmonary Medicine
Zip code	204-8585
Address	3-1-1 Takeoka, Kiyose, Tokyo, Japan
TEL	+81424912111
Homepage URL
Email	shinjit-tky@umin.ac.jp

Sponsor
Institute	National Hospital Organization, Tokyo National Hospital
Institute
Department

Funding Source
Organization	Ministry of Healthy, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	NHO Tokyo national hispital
Address	3-1-1 Tateoka Kiyose-shi Tokyo
Tel	042-491-2111
Email	shinjit-tky@umin.ac.jp

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	2010 Year 01 Month 27 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	20
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	2010 Year 01 Month 27 Day
Date of IRB	2010 Year 02 Month 28 Day
Anticipated trial start date	2010 Year 01 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 01 Month 27 Day
Last modified on	2020 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003772