UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003108
Receipt number R000003772
Scientific Title Clinical efficacy, saftey and pharmacodynamics of antifungal agents on chronic pulmonary mycosis
Date of disclosure of the study information 2010/01/27
Last modified on 2020/08/06 04:15:50

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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 or person

Institute

National Hospital Organization, Tokyo National Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003772


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name