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) studied | Methicillin-resistant Staphylococcus aureus infection |
| Date of first enrollment | 2009/03/01 |
| Target sample size | 10 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| 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 Outcome | Efficay and safety at the end of administartion |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Nagasaki University Graduate School of Biomedical Sciences |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Nagasaki Evaluation Organization for Cinical Interventions |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| 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 | |
| Affiliation | Nagasaki University Graduate School of Biomedical Sciences Department of Molecular Microbiology and Immunology |