Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

Study Overview
=================
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.

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.

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

Conditions
-----------------
Neutropenia, Cancer, Fever

Intervention / Treatment
-----------------
* Drug: cloxacillin and amikacin (once or twice daily dosage)


Participation Criteria
=================
Eligibility 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 limit Received aminoglycoside within 14 days prior to enrolment Received any intravenous antibiotics within 7 days Cancer which is newly diagnosed or relapsed

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cloxacillin and amikacin (once or twice daily dosage)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Afebrile within 5 days of the initial treatment regimen |  |  | 
| Nephrotoxicity and ototoxicity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost difference |  |  | 
| Pharmacokinetic parameters of amikacin in these children |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
febrile neutropenia, once-daily, amikacin, cloxacillin, children