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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