Status:

COMPLETED

Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

Lead Sponsor:

Khon Kaen University

Collaborating Sponsors:

National Research Council of Thailand

Conditions:

Neutropenia

Cancer

Eligibility:

All Genders

1-14 years

Phase:

NA

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...

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 Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2002

Trial Type :

INTERVENTIONAL

End Date :

June 1 2004

Estimated Enrollment :

166 Patients enrolled

Trial Details

Trial ID

NCT00129688

Start Date

April 1 2002

End Date

June 1 2004

Last Update

September 23 2005

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