Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children
Comparison of Efficacy, Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With Cloxacillin in Febrile Neutropenic Children
2 other identifiers
interventional
166
0 countries
N/A
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2002
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 10, 2005
CompletedFirst Posted
Study publicly available on registry
August 12, 2005
CompletedSeptember 23, 2005
February 1, 2005
August 10, 2005
September 22, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Afebrile within 5 days of the initial treatment regimen
Nephrotoxicity and ototoxicity
Secondary Outcomes (2)
Cost difference
Pharmacokinetic parameters of amikacin in these children
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Khon Kaen Universitylead
- National Research Council of Thailandcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pope - Kosalaraksa, M.D.
Faculty of Medicine, Khon Kaen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 10, 2005
First Posted
August 12, 2005
Study Start
April 1, 2002
Study Completion
June 1, 2004
Last Updated
September 23, 2005
Record last verified: 2005-02