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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorGadjah Mada University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ceftazidime

    Drug

    Ceftazidime 150 mg/kgBW/24 hours divided into 3 doses.

  • Ciprofloxacin

    Drug

    Ciprofloxacin 10 mg/kgBW/12 hours

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Group AActive comparator 1 intervention
Group B: Group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Duration of fever

Duration of fever since receiving the first antibiotic, based on the temperature graph available in the electronic medical record

Time frame
from first administration of Ciprofloxacin or Ceftazidime to 48 hours fever free
2

Duration of Neutropenia

The length of time the subject experiences neutropenia, absolute neutrophil count is \<500

Time frame
From first antibiotic administration to 48 hours after administration

Secondary outcomes

1

Duration of hospitalization

The duration from the date of subject recruitment to the date of hospital discharge, as recorded in the electronic medical record.

Time frame
From first administration of Ciprofloxacin or Ceftazidime to hospital discharge
2

Duration of antibiotic use

days of antibiotic use from the first administration to the last intravenous antibiotic administration

Time frame
days from first administration to the last intravenous antibiotic administration
3

Antibiotic escalation decisions

Clinician decisions in escalating empirical antibiotics to second-line antibiotics

Time frame
From first administration of Ciprofloxacin or Ceftazidime to 48 hours after administration
4

Mortality

Mortality of subject in admission is proven by a death certificate

Time frame
from first administration of ciprofloxacin or ceftazidime to 30 days after recruitment

Other outcomes

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