UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003161 |
|---|---|
| Receipt number | 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 09:38:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tetsuya@tokyo-med.ac.jp
Sponsor or person
Institute
Kitasato University Research Center for Anti-infection Drugs
Institute
Department
Personal name
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
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
Value
https://center6.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 |
