Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children
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|ClinicalTrials.gov Identifier: NCT00129688|
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : September 23, 2005
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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 or disease||Intervention/treatment||Phase|
|Neutropenia Cancer Fever||Drug: cloxacillin and amikacin (once or twice daily dosage)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Efficacy, Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With Cloxacillin in Febrile Neutropenic Children|
|Study Start Date :||April 2002|
|Study Completion Date :||June 2004|
- Afebrile within 5 days of the initial treatment regimen
- Nephrotoxicity and ototoxicity
- Cost difference
- Pharmacokinetic parameters of amikacin in these children
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|Ages Eligible for Study:||1 Year to 14 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129688
|Principal Investigator:||Pope - Kosalaraksa, M.D.||Faculty of Medicine, Khon Kaen University|
|Other Study ID Numbers:||
|First Posted:||August 12, 2005 Key Record Dates|
|Last Update Posted:||September 23, 2005|
|Last Verified:||February 2005|