Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children
Once-daily dose administration of aminoglycoside in adults is effective and economical. However, its value in febrile neutropenic children, especially in Thailand, is less well researched. In the area where Pseudomonas aeruginosa prevalence in febrile neutropenic children is low, the combination of cloxacillin and amikacin is an appropriate approach. This study would like to compare the efficacy and safety including cost between these two amikacin administrations (once-daily or twice-daily) in combination with cloxacillin as an empirical therapy in febrile neutropenic children.
Hypothesis: Once-daily amikacin plus cloxacillin can be used to treat febrile neutropenic children in Khon Kaen, Thailand.
Drug: cloxacillin and amikacin (once or twice daily dosage)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Efficacy, Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With Cloxacillin in Febrile Neutropenic Children|
- Afebrile within 5 days of the initial treatment regimen
- Nephrotoxicity and ototoxicity
- Cost difference
- Pharmacokinetic parameters of amikacin in these children
|Study Start Date:||April 2002|
|Estimated Study Completion Date:||June 2004|
Fever: a single oral temperature of >/= 38.3 degrees C; or >/= 38.0 degrees C for >/= 1 hour.
Neutropenia: neutrophil count, < 500/cu mm or <1,000/cu mm with a predicted decrease to <500/mm3.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129688
|Principal Investigator:||Pope - Kosalaraksa, M.D.||Faculty of Medicine, Khon Kaen University|