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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00129688

Enrollment

166

Registered

2005-08-12

Start date

2002-04-30

Completion date

2004-06-30

Last updated

2005-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Fever, Neutropenia

Keywords

febrile neutropenia, once-daily, amikacin, cloxacillin, children

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.

Interventions

DRUGcloxacillin and amikacin (once or twice daily dosage)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 14 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Afebrile within 5 days of the initial treatment regimen	—
Nephrotoxicity and ototoxicity	—

Secondary

Measure	Time frame
Cost difference	—
Pharmacokinetic parameters of amikacin in these children	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026