UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001770 |
|---|---|
| Receipt number | R000002129 |
| Scientific Title | Efficacy of high dose of arbekacin once daily administration for methicillin-resistant Staphylococcus aureus infection |
| Date of disclosure of the study information | 2009/03/12 |
| Last modified on | 2012/02/15 17:29:54 |
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Basic information
Public title
Efficacy of high dose of arbekacin once daily administration for methicillin-resistant Staphylococcus aureus infection
Acronym
Efficacy of high dose ABK for MRSA infection
Scientific Title
Efficacy of high dose of arbekacin once daily administration for methicillin-resistant Staphylococcus aureus infection
Scientific Title:Acronym
Efficacy of high dose ABK for MRSA infection
Region
| Japan |
Condition
Condition
Methicillin-resistant Staphylococcus aureus infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety of high dose arbekacin administartion for MRSA infection
Basic objectives2
Others
Basic objectives -Others
Evaluation of serum ABK concentration and efficay and sefety
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficay and safety at the end of administartion
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 |
Interventions/Control_1
Dose:
Primary administartion dose is caluculated by ABK TDM software ver. 2.1. ABK is injected once daily by 60 minutes. recommended serum ABK concentratios are 20 micro g/ml at peak and 2 micro g/ml at trough.
Duration:
Seven days. Maximum 14 days.
On day three, torough level of ABK is measured and the dose can be changed.
Treatment can be discontinued before 14 days if the pateint is recovered.
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
Patinets with suspected or defined pneumonia or sepsis due to MRSA, who satisfied the all conditions below;
Patients who are
1) hospitalized
2) above 20 years old
3) male or female
4) able to understand and sign the agreement of participation to this clinical trial. (subistitutional agreement of relatives to participate to trail is allowed)
Key exclusion criteria
Patients with
1) allergy to aminoglycoside drugs
2) hearing disturbance due to aminoglycoside
3) severe renal or live dysfunction
4) hemodialysis
5) pregnant or breast feeding
6) needs drugs which is prohibited to use in this protocol
7) BW: below 40mg
8) neutrophil count is below 500 /mm3
9) others; attending physician decided to inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Kohno |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Molecular Microbiology and Immunology
Zip code
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Molecular Microbiology and Immunology
Zip code
Address
TEL
Homepage URL
yyamamo@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Evaluation Organization for Cinical Interventions
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 03 | Month | 12 | 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
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2009 | 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
| 2009 | Year | 03 | Month | 12 | Day |
Last modified on
| 2012 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002129
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
