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

Phase 4

Not yet recruiting

• Conditions: Neutropenic Fever; Acute Lymphoblastic Leukemia; Acute Myeloblastic Leukemia; Non Hodgkin Lymphoma
• Interventions: Drug: Ciprofloxacin; Drug: Ceftazidime

• Registration Number: NCT07016165
• Lead Sponsor: Gadjah Mada University

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 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.

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 fever.

2. 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.

3. Compare the mortality of pediatric patients with high-risk neutropenic fever due to hematological malignancies who received empirical antibiotic therapy of ceftazidime and ciprofloxacin.

4. 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 Timeline

• Study First Submitted: 2025-05-30
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Study Start: 2025-06-15
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Ciprofloxacin	Standard therapy IV ciprofloxacin 10 mg/kgBW/12 hours
Group B	Ceftazidime	IV ceftazidime 150 mg/kgBW/24 hours divided into 3 doses

Primary Outcome Measures

Name	Time	Method
Duration of fever	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	From first antibiotic administration to 48 hours after administration	The length of time the subject experiences neutropenia, absolute neutrophil count is \<500

Secondary Outcome Measures

Name	Time	Method
Duration of hospitalization	From first administration of Ciprofloxacin or Ceftazidime to hospital discharge	The duration from the date of subject recruitment to the date of hospital discharge, as recorded in the electronic medical record.
Duration of antibiotic use	days from first administration to the last intravenous antibiotic administration	days of antibiotic use from the first administration to the last intravenous antibiotic administration
Antibiotic escalation decisions	From first administration of Ciprofloxacin or Ceftazidime to 48 hours after administration	Clinician decisions in escalating empirical antibiotics to second-line antibiotics
Mortality	from first administration of ciprofloxacin or ceftazidime to 30 days after recruitment	Mortality of subject in admission is proven by a death certificate

Trial Locations

Locations (1)

RSUP dr Sardjito; 🇮🇩 Sleman, DI Yogyakarta, Indonesia