Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

Condition(s) targeted: Neutropenia; Cancer; Fever

Intervention: cloxacillin and amikacin (once or twice daily dosage) (Drug)

Phase: N/A

Status: Completed

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

Primary outcome:

Afebrile within 5 days of the initial treatment regimen

Nephrotoxicity and ototoxicity

Secondary outcome:

Cost difference

Pharmacokinetic parameters of amikacin in these children

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.

Minimum age: 1 Year. Maximum age: 14 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Aged 1 year - 14 years

- 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.

- During the course of chemotherapy

Exclusion Criteria:

- 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

Starting date: April 2002
Last updated: September 22, 2005