UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017874 |
|---|---|
| Receipt number | R000020708 |
| Scientific Title | The safety and feasibility of inhaled amikacin for treatment of refractory chronic lower respiratory tract infections |
| Date of disclosure of the study information | 2015/06/11 |
| Last modified on | 2017/04/09 22:40:47 |
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Basic information
Public title
The safety and feasibility of inhaled amikacin for treatment of refractory chronic lower respiratory tract infections
Acronym
Inhaled amikacin for treatment of refractory chronic lower respiratory tract infections
Scientific Title
The safety and feasibility of inhaled amikacin for treatment of refractory chronic lower respiratory tract infections
Scientific Title:Acronym
Inhaled amikacin for treatment of refractory chronic lower respiratory tract infections
Region
| Japan |
Condition
Condition
chronic lower respiratory tract infections
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and feasibility of inhaled amikacin for treatment of refractory chronic lower respiratory tract infections
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Microbiological examination from lower respiratory tract specimens, Clinical symptoms, Radiological examination, Adverse events
Key secondary outcomes
Base
Study type
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
Inhaled amikacin therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study population consisted of the patients with refractory chronic lower respiratory tract infections, such as nontuberculous mycobacterial lung disease, who attended a university hospital as outpatients.
Key exclusion criteria
Drug allergy of amikacin
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Hasegawa |
Organization
Keio University School of Medicine
Division name
Center for Infectious Diseases and Infection Control
Zip code
Address
35 Shinanomachi Shinjuku-ku, Tokyo 160-8582, Japan
TEL
0333531211
n-hasegawa@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Hasegawa |
Organization
Keio University School of Medicine
Division name
Center for Infectious Diseases and Infection Control
Zip code
Address
35 Shinanomachi Shinjuku-ku, Tokyo 160-8582, Japan
TEL
0333531211
Homepage URL
n-hasegawa@z8.keio.jp
Sponsor or person
Institute
Center for Infectious Diseases and Infection Control, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Center for Infectious Diseases and Infection Control, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 11 | Day |
Last modified on
| 2017 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020708
