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
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
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
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
