About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Ceftazidime
DrugCeftazidime 150 mg/kgBW/24 hours divided into 3 doses.
Ciprofloxacin
DrugCiprofloxacin 10 mg/kgBW/12 hours
Treatment groups
Trial outcomes
Primary outcomes
Duration of fever
Duration of fever since receiving the first antibiotic, based on the temperature graph available in the electronic medical record
Duration of Neutropenia
The length of time the subject experiences neutropenia, absolute neutrophil count is \<500
Secondary outcomes
Duration of hospitalization
The duration from the date of subject recruitment to the date of hospital discharge, as recorded in the electronic medical record.
Duration of antibiotic use
days of antibiotic use from the first administration to the last intravenous antibiotic administration
Antibiotic escalation decisions
Clinician decisions in escalating empirical antibiotics to second-line antibiotics
Mortality
Mortality of subject in admission is proven by a death certificate
Sponsors and contacts
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