NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001770

Registered date:12/03/2009

Efficacy of high dose of arbekacin once daily administration for methicillin-resistant Staphylococcus aureus infection

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMethicillin-resistant Staphylococcus aureus infection
Date of first enrollment2009/03/01
Target sample size10
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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.

Outcome(s)

Primary OutcomeEfficay and safety at the end of administartion
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPatients 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

Related Information

Contact

public contact
Name
Address Japan
Telephone
E-mail yyamamo@nagasaki-u.ac.jp
Affiliation Nagasaki University Graduate School of Biomedical Sciences Department of Molecular Microbiology and Immunology
scientific contact
Name Shigeru Kohno
Address 1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN Japan
Telephone
E-mail
Affiliation Nagasaki University Graduate School of Biomedical Sciences Department of Molecular Microbiology and Immunology