Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

This study has been completed.
Sponsor:
Collaborator:
National Research Council of Thailand
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00129688
First received: August 10, 2005
Last updated: September 22, 2005
Last verified: February 2005
  Purpose

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.


Condition Intervention
Neutropenia
Cancer
Fever
Drug: cloxacillin and amikacin (once or twice daily dosage)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Efficacy, Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With Cloxacillin in Febrile Neutropenic Children

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Afebrile within 5 days of the initial treatment regimen
  • Nephrotoxicity and ototoxicity

Secondary Outcome Measures:
  • Cost difference
  • Pharmacokinetic parameters of amikacin in these children

Estimated Enrollment: 166
Study Start Date: April 2002
Estimated Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   1 Year to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00129688

Sponsors and Collaborators
Khon Kaen University
National Research Council of Thailand
Investigators
Principal Investigator: Pope - Kosalaraksa, M.D. Faculty of Medicine, Khon Kaen University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00129688     History of Changes
Other Study ID Numbers: HE44290, 40/2545
Study First Received: August 10, 2005
Last Updated: September 22, 2005
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
febrile neutropenia
once-daily
amikacin
cloxacillin
children

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Amikacin
Cloxacillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014