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/
Not Applicable
Recruiting
- Conditions
- Methicillin-resistant Staphylococcus aureus (MRSA) infection
- Registration Number
- JPRN-UMIN000003161
- Lead Sponsor
- Kitasato University Research Center for Anti-infection Drugs
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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 +).