Clinical significance of arbekacin for MRSA infection in patients with hematological malignancies based on the PK-PD index
Not Applicable
- Conditions
- Methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with hematological malignancies (including probable cases).
- Registration Number
- JPRN-UMIN000004426
- Lead Sponsor
- ihon University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who have received any other anti-MRSA agents (vancomycin, teicoplanin, linezolid) within 2 weeks before administration of arbekacin. 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 with a medical history or a family history of deafness induced by aminoglycoside antibiotics, or other patients with deafness. 5) Patients on any form of dialysis (hemodialysis: HD; continuous ambulatory peritoneal dialysis: CAPD; continuous hemodiafiltration, CHDF). 6) Patients deemed unsuitable for enrollment by the physician in charge 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 "effective" if the symptoms of infection have disappeared or significantly improved, taking into account the body temperature, heart rate, white blood cell count, etc. at baseline and after completion/discontinuation of the treatment. Toxicity rating: Adverse events caused by administration of arbekacin will be rated as followings. i) Leading to death ii) Life threatening iii) Requiring hospitalization or prolongation of hospital stay iv) Leading to ever lasting malfunction v) Leading to congenital malformation or deficiency vi) Any other adverse events considered clinically serious vii) Any adverse event not applicable to i) - iv)
- Secondary Outcome Measures
Name Time Method 1)Effectiveness and clinical parameters; actual Cmax (or Cmax/MIC), probability of changing to other anti-MRSA drugs, CRP value before and after the treatment. 2)Factors influencing clinical outcome; evaluating patients' characteristics associated with effectiveness and toxicity. 3)Bacteriological response rating; actual isolate changes before and after the treatment.