NCT00129688

Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (planned)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 1 Year – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neutropenia
• Cancer
• Fever

Interventions

Type	Name	Description
DRUG	cloxacillin and amikacin (once or twice daily dosage)

Timeline

• Start date: 2002-04-01
• Completion: 2004-06-01
• First posted: 2005-08-12
• Last updated: 2005-09-23