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Therapeutic monitoring of Amikacin Regimen Associated Toxicity in Febrile neutropenic Pediatric Cancer Patients

Research Authors
Abdel-Azim Assi, Safaa A. and Aya Sayed
Research Date
Research Department
Research Journal
AS Pharmaceutical Sciences Journal
Research Abstract

 

Aim of  work:

1-Evaluation of amikacin serum level in pediatric cancer patients with fever, neutropenia and impact of this level on the efficacy and toxicity of Amikacin.

2-Comparison between once versus twice daily regimens of amikacin will be done to know which regimen is most effective and less toxic.

Patients and methodology:

Inclusion Criteria:

1-Pediatric patients aged from 1-12 years.                                                           

2-patients with hematological malignancies admitted to South Egypt Cancer Institute,    Assiut University.                                                                                                                                  3-patients with normal renal and hearing function.

Exclusion Criteria:                                               

1-patients below one year.         

2-patients have renal or hearing dysfunction.                                                                                             

3-patients receive drugs which affect renal function.

Written informed consent was obtained from parents of the children. Patients with hematological malignancies admitted to South Egypt Cancer Institute, Assiut University to be treated empirically with intravenous amikacin for neutropenic fever, were participate in the study.

50 pediatric patients were randomly assigned to receive 15 mg/kg amikacin (amikacin salphate vail)   intravenously either once a day or divided in two equal doses every 12 h by 30 minute infusion, with maximum dose of 1 gm per day .

     Amikacin serum concentrations will analyzed at Pharmacokinetic Laboratory , South Egypt Cancer Institute.  Amikacin will be measured by means of homogeneous enzyme immunoassay using Viva Emit® assay (Siemens Healthcare Diagnostics, USA). Peak of amikacin concentrations will be obtained after one hour from starting intravenous infusion and concentrations will be obtained 8-12h after the last dose for all patients.                  

Renal function and hearing function will be assessed by measuring serum creatinine (Nephrotoxicity was defined as the increase of 0.5 mg/dl [50 lmol/L] from baseline value.)  and audiogram respectively before and after the treatment. Comparison between once versus twice daily regimens of amikacin will be done to know which regimen is most effective and less toxic.