NCT07016165RecruitingPhase 4
Ciprofloxacin Versus Ceftazidime as Empirical Therapy of High-Risk Neutropenic Fever in Children With Hematologic Malignancies : A Randomized Controlled Trial
Gadjah Mada University1 site in 1 country120 target enrollmentStarted: June 1, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Duration of fever
Study Overview
Brief Summary
This clinical trial will compare use of ciprofloxacin and ceftazidime work in treating high-risk fever in children with hematological malignancies
- 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?
- 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.
Detailed Description
Furthermore, this clinical trial aims to:
- Compare the efficacy of empirical antibiotic administration of Ciprofloxacin and Ceftazidime in pediatric malignancy patients with high-risk neutropenic fever.
- Analyze the differences in clinical effectiveness between ceftazidime and ciprofloxacin antibiotics based on the duration of fever, duration of neutropenia, duration of hospitalization in high-risk neutropenic fever in children with hematological malignancies.
- Compare the mortality of pediatric patients with high-risk neutropenic fever due to hematological malignancies who received empirical antibiotic therapy of ceftazidime and ciprofloxacin.
- Compare antibiotic escalation decisions in pediatric patients with high-risk neutropenic fever due to hematological malignancies who received empirical antibiotic therapy of ceftazidime and ciprofloxacin.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Group A
Active Comparator
Standard therapy IV ciprofloxacin 10 mg/kgBW/12 hours
Intervention: Ciprofloxacin (Drug)
Group B
Experimental
IV ceftazidime 150 mg/kgBW/24 hours divided into 3 doses
Intervention: Ceftazidime (Drug)
Outcomes
Primary Outcomes
Duration of fever
Time Frame: from first administration of Ciprofloxacin or Ceftazidime to 48 hours fever free
Duration of fever since receiving the first antibiotic, based on the temperature graph available in the electronic medical record
Duration of Neutropenia
Time Frame: From first antibiotic administration to 48 hours after administration
The length of time the subject experiences neutropenia, absolute neutrophil count is \<500
Secondary Outcomes
- Duration of hospitalization(From first administration of Ciprofloxacin or Ceftazidime to hospital discharge)
- Duration of antibiotic use(days from first administration to the last intravenous antibiotic administration)
- Antibiotic escalation decisions(From first administration of Ciprofloxacin or Ceftazidime to 48 hours after administration)
- Mortality(from first administration of ciprofloxacin or ceftazidime to 30 days after recruitment)
Investigators
Bambang Ardianto
Principal Investigator, Head of Pediatric Hematolo-Oncology Divison
Gadjah Mada University
Study Sites (1)
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