drugset / Trial / NCT07016165

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

NCT07016165

Phase 4 Recruiting 120 enrolled Gadjah Mada University
RandomizedParallel-groupOpen-labelTreatment

Summary

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: one group will receive the standard treatment with intravenous ciprofloxacin, while the other group will receive the intervention treatment with intravenous ceftazidime. * Both groups will be monitored for various outcomes, including the length of fever, length of low white blood cell count, length of hospital stay, length of antibiotic use, any changes in antibiotics, and mortality.

Timeline

Start
2025-06-01
Primary completion
2025-11-30
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceftazidime Small molecule 150 mg/kg Intravenous
Comparator Ciprofloxacin Small molecule 10 mg/kg Intravenous