Trial | NCT00129688  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    amikacin cloxacillin ...

  • Study Participants

    166
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.
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.
Study Started
Apr 30
2002
Study Completion
Jun 30
2004
Last Update
Sep 23
2005
Estimate

Drug cloxacillin and amikacin (once or twice daily dosage)

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
No Results Posted