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

Official title

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

Overview

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.

Interventions

• Drug Ceftazidime
  Ceftazidime 150 mg/kgBW/24 hours divided into 3 doses.
• Drug Ciprofloxacin
  Ciprofloxacin 10 mg/kgBW/12 hours

Primary outcome measures

• Duration of fever [Time frame: from first administration of Ciprofloxacin or Ceftazidime to 48 hours fever free]
• Duration of Neutropenia [Time frame: From first antibiotic administration to 48 hours after administration]

Secondary outcome measures (4)

• Duration of hospitalization [Time frame: From first administration of Ciprofloxacin or Ceftazidime to hospital discharge]
• Duration of antibiotic use [Time frame: days from first administration to the last intravenous antibiotic administration]
• Antibiotic escalation decisions [Time frame: From first administration of Ciprofloxacin or Ceftazidime to 48 hours after administration]
• Mortality [Time frame: from first administration of ciprofloxacin or ceftazidime to 30 days after recruitment]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Indonesia · 1 center

• RSUP dr Sardjito — Sleman

Publications

• Corapcioglu F, Sarper N. Cefepime versus ceftazidime + amikacin as empirical therapy for febrile neutropenia in children with cancer: a prospective randomized trial of the treatment efficacy and cost. Pediatr Hematol Oncol. 2005 Jan-Feb;22(1):59-70. doi: 10.1080/08880010590896297. PMID 15770833
• Kamonrattana R, Sathitsamitphong L, Choeyprasert W, Charoenkwan P, Natesirinilkul R, Fanhchaksai K. A Randomized, Open-Labeled, Prospective Controlled Study to Assess the Efficacy of Frontline Empirical Intravenous Piperacillin/Tazobactam Monotherapy in Comparison with Ceftazidime Plus Amikacin for Febrile Neutropenia in Pediatric Oncology Patients. Asian Pac J Cancer Prev. 2019 Sep 1;20(9):2733-2 PMID 31554370
• Yasuda T, Suzuki R, Ishikawa Y, Terakura S, Inamoto Y, Yanada M, Nagai H, Ozawa Y, Ozeki K, Atsuta Y, Emi N, Naoe T. Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematological malignancies. Int J Infect Dis. 2013 Jun;17(6):e385-90. doi: 10.1016/j.ijid.2012.12.005. Epub 2013 Jan 11. PMID 23317527

Identifiers

NCT: NCT07016165 · KE/FK/0517/EC/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗