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NCT Number: NCT07016165

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ceftazidime

Drug

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

Ciprofloxacin

Drug

Ciprofloxacin 10 mg/kgBW/12 hours

Primary outcomes

  1. 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

  2. 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

  1. Duration of hospitalization

    Time frame: 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.

  2. Duration of antibiotic use

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

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

  3. Antibiotic escalation decisions

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

    Clinician decisions in escalating empirical antibiotics to second-line antibiotics

  4. Mortality

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

    Mortality of subject in admission is proven by a death certificate

Study contacts

Contact information is provided by the study sponsor or research team.

dr. Khairunisa Rahma Handayani, Medical doctor

CONTACT

[email protected]

+6281246572652

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Official study title

Ciprofloxacin Versus Ceftazidime as Empirical Therapy of High-Risk Neutropenic Fever in Children With Hematologic Malignancies : A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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