Cefepime versus ceftazidime + amikacin as empirical therapy for febrile neutropenia in children with cancer: a prospective randomized trial of the treatment efficacy and cost.
Funda Corapçioglu, Nazan Sarper
https://pubmed.ncbi.nlm.nih.gov/15770833Actively Recruiting
Phase 4
Age: 0 - 18Years
All Genders
ID07016165
Ciprofloxacin Versus Ceftazidime as Empirical Therapy of High-Risk Neutropenic Fever in Children With Hematologic Malignancies: A Randomized Controlled Trial
Led by Gadjah Mada University · Updated on 2025-08-22
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the use of ciprofloxacin and ceftazidime in treating high-risk fever caused by low neutrophil count in children with hematological malignancies. It focuses on children aged 0 to 18 years diagnosed with blood cancers such as acute lymphoblastic leukemia, acute myeloblastic leukemia, and non-Hodgkin lymphoma. The study evaluates which antibiotic works better as a first-choice treatment and investigates factors influencing response to these drugs. Participants will be randomly assigned to receive either intravenous ciprofloxacin at 10 mg/kg every 12 hours or intravenous ceftazidime at 150 mg/kg per day divided into three doses. The treatments are given during hospitalization between June and December 2025. Both groups will be monitored for outcomes like the length of fever, duration of low white blood cell count, hospital stay length, antibiotic use duration, any changes in antibiotic treatment, and death rates. Throughout the trial, participants will undergo medical history collection, physical exams, and supportive tests. Researchers will track key measures including duration of fever and neutropenia from the start of antibiotic treatment, hospitalization duration, and antibiotic escalation decisions. Safety and mortality will also be assessed up to 30 days after enrollment. This comprehensive monitoring aims to understand the effectiveness and clinical impact of these antibiotics in managing high-risk neutropenic fever in children with blood cancers.
CONDITIONS
Brief Title
Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies
Who Can Participate
Age: 0 - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children aged 0 to 18 years with hematological malignancies
- Children with high-risk neutropenic fever diagnosed by a pediatrician, including phases of acute lymphoblastic leukemia, acute myeloblastic leukemia, and non-Hodgkin lymphoma
- Consent from parents to include the child in the study
You will not qualify if you...
- Children with malignancies who also have comorbidities like HIV infection or septic shock
- Allergy to ciprofloxacin or ceftazidime
- Fever caused by blood transfusion reactions
- Receiving other antibiotics within 72 hours prior to the study, except for certain prophylactic antibiotics
- Children with impaired kidney function (serum creatinine ≥ 1.5 times upper normal limit) or impaired liver function (SGPT > 5 times upper normal limit)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of antibiotic use from first administration to last intravenous dose
Participants receive empirical antibiotic therapy with either Ciprofloxacin or Ceftazidime to treat high-risk neutropenic fever.
Visits occur during antibiotic administration as per treatment schedule
Follow-up
Duration - Up to 30 days after recruitment
Participants are monitored for outcomes including duration of fever, neutropenia, hospitalization, antibiotic escalation decisions, and mortality.
Follow-up visits as scheduled up to 30 days post-treatment
Trial Site Locations
Total: 1 location
1
RSUP dr Sardjito
Sleman, DI Yogyakarta, Indonesia
Actively Recruiting
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Research Team
D
dr. Khairunisa Rahma Handayani, Medical doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.
Ruchirek Kamonrattana, Lalita Sathitsamitphong, Worawut Choeyprasert...
https://pubmed.ncbi.nlm.nih.gov/31554370Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematological malignancies.
Takahiko Yasuda, Ritsuro Suzuki, Yuichi Ishikawa...
https://pubmed.ncbi.nlm.nih.gov/23317527