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| ID | Type | Description | Link |
|---|---|---|---|
| 40/2545 |
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| Name | Class |
|---|---|
| National Research Council of Thailand | OTHER_GOV |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cloxacillin and amikacin (once or twice daily dosage) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Afebrile within 5 days of the initial treatment regimen | ||
| Nephrotoxicity and ototoxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Cost difference | ||
| Pharmacokinetic parameters of amikacin in these children |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pope - Kosalaraksa, M.D. | Khon Kaen University | Principal Investigator |
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| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D009369 | Neoplasms |
| D005334 | Fever |
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D003023 | Cloxacillin |
| D000583 | Amikacin |
| ID | Term |
|---|---|
| D010068 | Oxacillin |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |