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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008350
Receipt No. R000009821
Scientific Title Penetration of Arbekacin sulfate into epithelial lining fluid(ELF) of patients with pneumonia.
Date of disclosure of the study information 2012/07/05
Last modified on 2014/04/20

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Basic information
Public title Penetration of Arbekacin sulfate into epithelial lining fluid(ELF) of patients with pneumonia.
Acronym PK study of Arbekacin sulfate in ELF in patients with pneumonia.
Scientific Title Penetration of Arbekacin sulfate into epithelial lining fluid(ELF) of patients with pneumonia.
Scientific Title:Acronym PK study of Arbekacin sulfate in ELF in patients with pneumonia.
Region
Japan

Condition
Condition Pneumonia
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate Pharmacokinetics(PK) and lung translatability of Arbekacin sulfate in ELF in inflammatory situation by bronchoscopic microsampling(BMS) analysis on patients with pneumonia.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate PK in serum and ELF of Arbekacin sulfate, the ratio ELF:serum of Arbekacin sulfate.
Key secondary outcomes To evaluate inflammatory cytokines (IL-1, IL-2, IL-6, IL-10, pro-calcitonine, etc) in serum after BMS.

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 Infusing 200mg of Arbekacin sulfate diluted in 100ml of normal 0.9% saline solution in an hour. Amount of Arbekacin sulfate is adjusted to reach 20microg/ml of peak concentration.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with intubation or tracheotomy suspected of MRSA pneumonia.
Key exclusion criteria 1)History of hypersensitivity caused by lidocaine hydrochloride.
2)History of hypersensitivity caused by aminoglycoside antibiotics or bacitracin.
3)One who has family or patient's history of hearing loss caused by aminoglycoside antibiotics. One who has hearing loss caused by any other reasons.
4)Creatinine clearance <=30mL/min.
5)Smorker.
6)who can't undergo BMS because of bleeding tendency.
7)Any other participants whose condition is inappropriate for the evaluation of this clinical study, judged by the investigator.
Target sample size 4

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Hasegawa
Organization Keio University Hospital School of Medicine
Division name Infection Control Center
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, 162-8582, Japan
TEL 03-5363-3710
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Hasegawa
Organization Keio University Hospital, School of Medicine
Division name Infection Control Center
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, 162-8582, Japan
TEL 03-5363-3710
Homepage URL
Email

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Meiji Seika Pharma
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization None

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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 05 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 Terminated
Date of protocol fixation
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 04 Day
Last modified on
2014 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009821

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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