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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RSUP dr Sardjito

Sleman, DI Yogyakarta, Indonesia