Cancer Clinical Trial
Official title:
Comparison of Efficacy, Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With 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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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