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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002893
Receipt No. R000003528
Scientific Title Inhalation of tobramycin for the patients with persistent respiratory infection by Psudomonas aeruginosa
Date of disclosure of the study information 2009/12/14
Last modified on 2009/12/14

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Basic information
Public title Inhalation of tobramycin for the patients with persistent respiratory infection by Psudomonas aeruginosa
Acronym Inhalation of tobramycin
Scientific Title Inhalation of tobramycin for the patients with persistent respiratory infection by Psudomonas aeruginosa
Scientific Title:Acronym Inhalation of tobramycin
Region
Japan

Condition
Condition Persistent respiratory infection by Pseudomonas aeruginosa
Classification by specialty
Pneumology Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Treatment for the patients with persistent respiratory infection by Pseudomonas aeruginosa
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Appearance and amount of airway secretions, culture of airway secretions, body temperature, white blood cell count, titer of CRP, PaO2/FiO2 ratio, and chest radiography
Key secondary outcomes

Base
Study type Interventional

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 Maneuver
Interventions/Control_1 Patients with persistent respiratory infection by Pseudomonas aeruginosa that are difficult to be cured with intravenous antibiotics are administered inhaled tobramycin with nebulizer.
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 Cases with persistent respiratory infection by Pseudomonas aeruginosa that are difficult to be cured with intravenous antibiotics.
Key exclusion criteria Cases with severe respiratory failure that require high density oxygen inhalation.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Kinoshita
Organization Kumamoto university hospital
Division name Emergency and critical care medicine
Zip code
Address 1-1-1 Honjo, Kumamoto, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kumamoto university hospital
Division name Emergency and critical care medicine
Zip code
Address
TEL 096-373-7031
Homepage URL
Email

Sponsor
Institute Kumamoto university hospital
Institute
Department

Funding Source
Organization Emergency and critical care medicine, Kumamoto university hospital
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
Address
Tel
Email

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
2009 Year 12 Month 14 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
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 Preinitiation
Date of protocol fixation
2009 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 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
2009 Year 12 Month 14 Day
Last modified on
2009 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003528

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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