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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003161
Receipt No. R000003835
Scientific Title Study of the Usefulness of Dosage and Administration of the Anti-MRSA Drug Arbekacin Sulfate (ABK) Set at a Peak Blood Concentration of 15-20 g/L
Date of disclosure of the study information 2010/03/01
Last modified on 2010/02/10

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Basic information
Public title Study of the Usefulness of Dosage and Administration of the Anti-MRSA Drug Arbekacin Sulfate (ABK) Set at a Peak Blood Concentration of 15-20 g/L
Acronym Study of the Usefulness of Dosage and Administration of ABK Set at a Peak Blood Concentration of 15-20 g/L
Scientific Title Study of the Usefulness of Dosage and Administration of the Anti-MRSA Drug Arbekacin Sulfate (ABK) Set at a Peak Blood Concentration of 15-20 g/L
Scientific Title:Acronym Study of the Usefulness of Dosage and Administration of ABK Set at a Peak Blood Concentration of 15-20 g/L
Region
Japan

Condition
Condition Methicillin-resistant Staphylococcus aureus (MRSA) infection
Classification by specialty
Pneumology Hematology and clinical oncology Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The relation between the blood concentrations and usefulness of the anti-MRSA drug Arbekacin (abbreviation: ABK; trade name: Habekacin injection; this drug below) will be investigated in patients who are being treated by appropriate administration according to drug blood concentration monitoring during the actual conditions of use of the new dosage and administration of this drug (approved February 29, 2008).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Efficacy rating:
The clinical response will be rated as good if symptoms of infection have disappeared or significantly improved, by taking account of body temperature, chest X-ray findings, WBC, CRP, PaO2/FiO2, etc. at baseline and at completion/discontinuation of the treatment.
Key secondary outcomes Bacteriological response rating:
Based on bacterial isolate changes at completion/discontinuation of study treatment compared to baseline, the bacteriological response will be rated as eliminated if the isolate has become eradicated or if symptoms have improved following the treatment, with disappearance of the organism from the initial lesion, and will be rated as diminished if there is a significant decrease of the isolate (by two grade change: from +++ to +).

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
Interventions/Control_1 Administration of antibiotic(ABK)
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adult patients with pneumonia or sepsis that is caused by or suspected of being caused by MRSA that is sensitive to this drug, who have given their consent to this study, and to whom this drug has been administered. However, administration will be discontinued whenever it is confirmed by the results of drug sensitivity testing that it is not sensitive to ABK
Key exclusion criteria 1) Patients who have received any other anti-MRSA drug (VCM, TEIC, LZD)
2) Patients with reduced renal function (creatinine clearance 30 ml/min/1.73 m2 or less)
3) Patients who are pregnant or might be pregnant
4) Patients who themselves or whose blood relatives have hearing loss caused by an aminoglycoside antibiotic, or other form of hearing loss
5) Patients on any form of dialysis (hemodialysis: HD; continuous ambulatory peritoneal dialysis: CAPD; continuous hemodiafiltration, CHDF)
6) Patients whom the physician in charge judges to be unsuitable for any other reason
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Sunakawa
Organization Kitasato Institute for Life Science
Division name Department of Research Project Studies
Zip code
Address 5-9-1 Shirokane,Minato-ku,Tokyo
TEL 03-5791-6463
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Matsumoto
Organization Tokyo Medical University
Division name Department of Microbiology
Zip code
Address 6-1-1 Shinjuku,shinjuku-ku,Tokyo
TEL 03-3351-6141
Homepage URL
Email tetsuya@tokyo-med.ac.jp

Sponsor
Institute Kitasato University Research Center for Anti-infection Drugs
Institute
Department

Funding Source
Organization None
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 医療法人社団こうかん会日本鋼管病院(神奈川県)
北里研究所病院(東京都)
北里大学病院(神奈川県)
国際医療福祉大学三田病院(東京都)
国家公務員共済組合連合会虎の門病院(東京都)
埼玉医科大学国際医療センター(埼玉県)
社会福祉法人恩賜財団済生会支部東京都済生会中央病院(東京都)
東京医科大学病院(東京都)
東京医科大学八王子医療センター(東京都)
東京女子医科大学病院(東京都)
千葉大学医学部附属病院(千葉県)
帝京大学医学部附属病院(東京都)
帝京大学医学部附属溝口病院(神奈川県)
獨協医科大学越谷病院(埼玉県)
日本医科大学付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 01 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 Open public recruiting
Date of protocol fixation
2008 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2010 Year 12 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
2010 Year 02 Month 10 Day
Last modified on
2010 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003835

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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