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


N/A
1 Year
14 Years
Not Enrolling
Both
Neutropenia, Cancer, Fever

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Afebrile within 5 days of the initial treatment regimen

Principal Investigator

Pope - Kosalaraksa, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Faculty of Medicine, Khon Kaen University

Authority:

Thailand: Khon Kaen University Ethics Committee for Human Research

Study ID:

HE44290

NCT ID:

NCT00129688

Start Date:

April 2002

Completion Date:

June 2004

Related Keywords:

  • Neutropenia
  • Cancer
  • Fever
  • febrile neutropenia
  • once-daily
  • amikacin
  • cloxacillin
  • children
  • Neutropenia

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