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

Gadjah Mada University

Status and phase: Enrolling; Phase 4

Conditions: Acute Myeloblastic Leukemia; Acute Lymphoblastic Leukemia; Non Hodgkin Lymphoma; Neutropenic Fever

Treatments: Drug: Ciprofloxacin; Drug: Ceftazidime

Study type: Interventional

Funder types: Other

Identifiers

NCT07016165

KE/FK/0517/EC/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Group A

Active Comparator group

Description:

Standard therapy IV ciprofloxacin 10 mg/kgBW/12 hours

Treatment:

Drug: Ciprofloxacin

Group B

Experimental group

Description:

IV ceftazidime 150 mg/kgBW/24 hours divided into 3 doses

Treatment:

Drug: Ceftazidime