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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 22, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 15, 2025 to Jun 1, 2025
    • Site details revised
    • Publications: details revised at 3 of 3 entries
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
2,948 trials monitored
See 180 trials at risk
and 1 more disease
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.
Trial Details
NCT Number NCT07016165
Lead Sponsor Gadjah Mada University
Conditions
(from sponsor)
Neutropenic Fever, Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia, Non Hodgkin Lymphoma
Related terms Febrile Neutropenia, Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov