Actively Recruiting
Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies
Led by Gadjah Mada University · Updated on 2025-08-22
120
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 0 to 18 years with hematological malignancies
- Children with high-risk neutropenic fever diagnosed by a pediatrician, including various phases of ALL, AML, and NHL
- Consent from parents to participate in the study
You will not qualify if you...
- Children with malignancies having comorbidities such as HIV infection or septic shock
- Allergy to ciprofloxacin or ceftazidime
- Fever caused by blood transfusion reactions
- Receiving other antibiotics within 72 hours before study entry, except cotrimoxazole or ciprofloxacin prophylaxis
- Impaired kidney function (serum creatinine ≥ 1.5 times upper normal limit) or liver function (SGPT > 5 times upper normal limit)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
RSUP dr Sardjito
Sleman, DI Yogyakarta, Indonesia
Actively Recruiting
Research Team
D
dr. Khairunisa Rahma Handayani, Medical doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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