UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001770
Receipt No. 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

* 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 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
Email

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
Email yyamamo@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

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
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

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
URL(English) https://upload.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


Contact us.