Status:
RECRUITING
Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies
Lead Sponsor:
Gadjah Mada University
Conditions:
Neutropenic Fever
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE4
Brief 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 a...
Detailed Description
Furthermore, this clinical trial aims to: 1. Compare the efficacy of empirical antibiotic administration of Ciprofloxacin and Ceftazidime in pediatric malignancy patients with high-risk neutropenic f...
Eligibility Criteria
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).
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07016165
Start Date
June 1 2025
End Date
December 31 2025
Last Update
August 22 2025
Active Locations (1)
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1
RSUP dr Sardjito
Sleman, DI Yogyakarta, Indonesia