Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Fever | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cloxacillin and amikacin (once or twice daily dosage) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Afebrile within 5 days of the initial treatment regimen
- measure
- Nephrotoxicity and ototoxicity
Secondary outcomes (2)
- measure
- Cost difference
- measure
- Pharmacokinetic parameters of amikacin in these children
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 14 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available