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Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children - Article


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Yellow Fever


Clinical Trial: Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

This study has been completed.

Sponsors and Collaborators: Khon Kaen University
National Research Council of Thailand
Information provided by: Khon Kaen University
ClinicalTrials.gov Identifier: NCT00129688

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 approached. This study would like to compare the efficacy and safety including cost between these 2 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: once or twice daily dosage

MedlinePlus related topics:  Blood and Blood Disorders;   Cancer;   Cancer Alternative Therapies;   Fever

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: 1. Afebrile within 5 days of the initial treatment regimen; 2. Nephrotoxicity and ototoxicity
Secondary Outcomes: 1. Cost difference; 2. Pharmacokinetic parameters of amikacin in these children
Expected Total Enrollment:  166

Study start: April 2002;  Study completion: May 2005
Last follow-up: June 2004;  Data entry closure: February 2005

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   -   14 Years,  Genders Eligible for Study:  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
  • Received aminoglycoside within 14 days prior to enrolment
  • Received any intravenous antibiotics within 7 days
  • Cancer which is newly diagnosed or relapsed

Location Information

Study chairs or principal investigators

Pope - Kosalaraksa, M.D.,  Principal Investigator,  Faculty of Medicine, Khon Kaen University   

More Information

Study ID Numbers:  HE44290; 40/2545
Last Updated:  August 11, 2005
Record first received:  August 10, 2005
ClinicalTrials.gov Identifier:  NCT00129688
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research
ClinicalTrials.gov processed this record on 2005-08-23


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Page Updated: October 1, 2005
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