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

Sponsor
Gadjah Mada University
Study ID
NCT07016165
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Ceftazidime — DRUG
    Ceftazidime 150 mg/kgBW/24 hours divided into 3 doses.
  • Ciprofloxacin — DRUG
    Ciprofloxacin 10 mg/kgBW/12 hours

Study Details

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.

Key Dates

First listed
Jun 11, 2025
Start date
Jun 1, 2025
Status verified
Jun 2025
Primary completion
Nov 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A
    Standard therapy IV ciprofloxacin 10 mg/kgBW/12 hours
  • Experimental: Group B
    IV ceftazidime 150 mg/kgBW/24 hours divided into 3 doses

Primary Outcome Measure

Duration of fever [ Time Frame: from first administration of Ciprofloxacin or Ceftazidime to 48 hours fever free ]

Central Contacts

Find similar trials

Nationwide
Leukemia (other) trialsOncology trialsBlood cancer trials

Related Studies