RecruitingPhase 4NCT07016165

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

Ciprofloxacin Versus Ceftazidime as Empirical Therapy of High-Risk Neutropenic Fever in Children With Hematologic Malignancies : A Randomized Controlled Trial


Sponsor

Gadjah Mada University

Enrollment

120 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two antibiotics — ciprofloxacin and ceftazidime — to find out which works better as an initial treatment for children with blood cancers who develop a fever while their white blood cell count is dangerously low (called neutropenic fever), a serious and common complication of cancer treatment. **You may be eligible if...** - You are a child between 0 and 18 years old - You have a blood cancer (such as leukemia or lymphoma) - You have developed high-risk neutropenic fever (fever with very low white blood cells) during a high-risk treatment phase - Your parents or guardians consent to study participation **You may NOT be eligible if...** - You have HIV or are in septic shock - You are allergic to ciprofloxacin or ceftazidime - You have had other antibiotics (other than specific preventive medications) in the past 72 hours - You have significantly impaired kidney or liver function - Your fever is due to a blood transfusion reaction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCeftazidime

Ceftazidime 150 mg/kgBW/24 hours divided into 3 doses.

DRUGCiprofloxacin

Ciprofloxacin 10 mg/kgBW/12 hours


Locations(1)

RSUP dr Sardjito

Sleman, DI Yogyakarta, Indonesia

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NCT07016165


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