UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety and feasibility of inhaled amikacin for treatment of refractory chronic lower respiratory tract infections
Title of the study (Brief title)	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	Naoki Hasegawa
Organization	Keio University School of Medicine
Division name	Center for Infectious Diseases and Infection Control
Address	35 Shinanomachi Shinjuku-ku, Tokyo 160-8582, Japan
TEL	0333531211
Email	n-hasegawa@z8.keio.jp

Public contact
Name of contact person	Naoki Hasegawa
Organization	Keio University School of Medicine
Division name	Center for Infectious Diseases and Infection Control
Address	35 Shinanomachi Shinjuku-ku, Tokyo 160-8582, Japan
TEL	0333531211
Homepage URL
Email	n-hasegawa@z8.keio.jp

Sponsor
Institute	Center for Infectious Diseases and Infection Control, Keio University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020708