Unique ID issued by UMIN | UMIN000008350 |
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Receipt number | 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 20:36:08 |
Penetration of Arbekacin sulfate into epithelial lining fluid(ELF) of patients with pneumonia.
PK study of Arbekacin sulfate in ELF in patients with pneumonia.
Penetration of Arbekacin sulfate into epithelial lining fluid(ELF) of patients with pneumonia.
PK study of Arbekacin sulfate in ELF in patients with pneumonia.
Japan |
Pneumonia
Medicine in general | Pneumology | Infectious disease |
Others
NO
To evaluate Pharmacokinetics(PK) and lung translatability of Arbekacin sulfate in ELF in inflammatory situation by bronchoscopic microsampling(BMS) analysis on patients with pneumonia.
Pharmacokinetics
Exploratory
Explanatory
Not applicable
To evaluate PK in serum and ELF of Arbekacin sulfate, the ratio ELF:serum of Arbekacin sulfate.
To evaluate inflammatory cytokines (IL-1, IL-2, IL-6, IL-10, pro-calcitonine, etc) in serum after BMS.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Medicine |
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.
20 | years-old | <= |
Not applicable |
Male and Female
Patients with intubation or tracheotomy suspected of MRSA pneumonia.
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.
4
1st name | |
Middle name | |
Last name | Naoki Hasegawa |
Keio University Hospital School of Medicine
Infection Control Center
35, Shinanomachi, Shinjuku-ku, Tokyo, 162-8582, Japan
03-5363-3710
1st name | |
Middle name | |
Last name | Naoki Hasegawa |
Keio University Hospital, School of Medicine
Infection Control Center
35, Shinanomachi, Shinjuku-ku, Tokyo, 162-8582, Japan
03-5363-3710
Keio University School of Medicine
Meiji Seika Pharma
Profit organization
None
NO
慶應義塾大学病院(東京都)
2012 | Year | 07 | Month | 05 | Day |
Unpublished
Terminated
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 07 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2012 | Year | 07 | Month | 04 | Day |
2014 | Year | 04 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009821
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