Spots Global Cancer Trial Database for Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

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Trial Identification

Brief Title: Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

Official Title: Comparison of Efficacy, Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With Cloxacillin in Febrile Neutropenic Children

Study ID: NCT00129688

Conditions

Neutropenia

Cancer

Fever

Interventions

cloxacillin and amikacin (once or twice daily dosage)

Study Description

Brief Summary: 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.

Detailed Description: 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.