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Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies

RecruitingPhase 4Ages any - 18 YearsAllGadjah Mada University
NCT07016165 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This clinical trial will compare use of ciprofloxacin and ceftazidime work in treating high-risk fever in children with hematological malignancies 1. Does ceftazidime work better than ciprofloxacin as a first-choice antibiotic for children with hematological malignancies who have high-risk fever from low neutrophil count? 2. Are there any specific factors that affect how children with hematological malignancies respond to ciprofloxacin or ceftazidime when treating high-risk fever? Participants in this study are children with hematological malignancies who have a high risk of fever due to low neutrophil count. Children, aged 0 to 18 years old, will be hospitalized between June and December 2025 at Sardjito General Hospital The study will involve: * Collecting patient history, conducting physical exams, and performing supporting tests. * Randomly assigning participants into two groups:

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📋 Eligibility rules (as published)
Inclusion Criteria: * Children aged 0 to 18 years with hematological malignancies. * Children with high-risk neutropenic fever, namely children with blood malignancies induction phase ALL, consolidation phase ALL, reinduction phase ALL, relapse ALL; meningeal ALL, AML, and NHL, diagnosed by a competent pediatrician on duty. * Consent from parents to be included in the study. Exclusion Criteria: * Children with malignancies but accompanied by comorbidities (HIV infection, septic shock). * Allergy to ciproloxacin or ceftazidime. * Fever associated with blood transfusion reactions. * Receiving other antibiotics since 72 hours before being included in the study, except for cotrimoxazole prophylaxis for the prevention of Pneumocystis carinii pneumonia, and ciproloxacin prophylaxis in AML. * Children with blood malignancies who have impaired renal function (serum creatinine ≥ 1.5 times the upper normal limit) and impaired liver function (SGPT \> 5 times the upper normal limit).
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What it tests

  • Ceftazidime
  • Ciprofloxacin
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Where

1 site
RSUP dr Sardjito
Sleman, Indonesia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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