Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children
Information source: Khon Kaen University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neutropenia; Cancer; Fever
Intervention: cloxacillin and amikacin (once or twice daily dosage) (Drug)
Sponsored by: Khon Kaen University
Official(s) and/or principal investigator(s):
Pope - Kosalaraksa, M.D., Principal Investigator, Affiliation: Faculty of Medicine, Khon Kaen University
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.
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Afebrile within 5 days of the initial treatment regimen
Nephrotoxicity and ototoxicity
Pharmacokinetic parameters of amikacin in these children
Fever: a single oral temperature of >/= 38. 3 degrees C; or >/= 38. 0 degrees C for >/= 1
Neutropenia: neutrophil count, < 500/cu mm or <1,000/cu mm with a predicted decrease to
Minimum age: 1 Year.
Maximum age: 14 Years.
- Aged 1 year - 14 years
- A single oral temperature of >/= 38. 3 degrees C; or >/= 38. 0 degrees C for >/= 1
- Neutropenia: neutrophil count, < 500/cu mm or <1,000/cu mm with a predicted decrease
- During the course of chemotherapy
- History of amikacin or cloxacillin allergy
- Creatinine clearance < 30 ml/min/m2
- Central nervous system infection: meningitis or brain abscess
- History of hearing abnormality
- Severely ill: shock
- Chronic liver diseases or SGPT > 10 times of upper normal limit
- Received aminoglycoside within 14 days prior to enrolment
- Received any intravenous antibiotics within 7 days
- Cancer which is newly diagnosed or relapsed
Locations and Contacts
Starting date: April 2002
Last updated: September 22, 2005