Methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with hematological malignancies (including probable cases).
Conditions
Interventions
Administration of antibiotic
Sponsors
Nihon University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients with hematological malignancies complicated with infection (including Febrile neutropenia) that is caused by or suspected of being caused by MRSA, who have given their consent to this study. However, administration will be discontinued whenever it is confirmed by the results of drug sensitivity testing that it is not sensitive to arbekacin.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKatsuhiro Miura
Nihon University School of Medicine Division of Hematology & Rheumatology
Outcome results
None listed