The Effect of Levofloxacin Prophylaxis on the First Occurrence of Febrile Neutropenia During Induction Chemotherapy in Pediatric Patients With Acute Lymphoblastic Leukemia at Dr. Sardjito Hospital
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Median time to first febrile neutropenia
研究概览
简要总结
The goal of this clinical trial is To evaluate the benefit of levofloxacin prophylaxis in prolonging the median time to first febrile neutropenia in pediatric ALL patients during induction phase. It will also learn about the safety of levofloxacin during induction treatment.
The main questions it aims to answer are:
- Does levofloxacin prophylaxis increase the median time to the first febrile neutropenia episode compared to placebo?
- What are the rates of fever, severe infection, organ-related bacterial infection, and mortality in children receiving levofloxacin compared to placebo?
Researchers will compare oral levofloxacin to a placebo (a look-alike substance with no active drug) to see if levofloxacin is effective in preventing infection during induction chemotherapy.
Participants will:
- Be children aged 1 to 18 years with ALL undergoing induction chemotherapy.
- Be randomly assigned to receive either levofloxacin prophylaxis or placebo during the induction phase.
- Have regular checkups, physical exams, and laboratory tests during induction.
- Be monitored for fever, febrile neutropenia, severe infections, bacterial infections, and mortality.
- Stop prophylaxis once the first febrile neutropenia occurs or induction therapy is completed.
详细描述
Furthermore, this clinical trial aims to:
- To determine the incidence of fever during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
- To determine the incidence of febrile neutropenia during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
- To determine the incidence of severe infections during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
- To determine the number of organ-related bacterial infections, whether microbiologically confirmed or not, during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
- To determine the mortality rate during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 1 to 18 years diagnosed with acute lymphoblastic leukemia (ALL).
- •Receiving induction phase 1A chemotherapy for ALL using the Indonesian National Childhood ALL Pilot Protocol 2024 Standard Risk; induction phases 1A and 1B chemotherapy using the Indonesian National Childhood ALL Pilot Protocol 2024 High Risk; or induction chemotherapy using the ACT4ALL Protocol 2025 at Dr. Sardjito Hospital.
- •No history of allergy to levofloxacin.
- •Parents/guardians provide written informed consent.
排除标准
- •Death before initiation of chemotherapy.
- •Patients with clinically or microbiologically confirmed infection within 72 hours prior to induction chemotherapy who require antibiotics for more than 5 days (to avoid antibiotic therapy as a confounding factor for antibiotic prophylaxis).
研究组 & 干预措施
Group A: Levofloxacin
Receiving oral levofloxacin as infection prophylaxis during the induction phase, with the following dosage:
- Age < 5 years: 10 mg/kg PO every 12 hours (maximum 250 mg/dose)
- Age ≥ 5 years: 10 mg/kg PO once daily (maximum 500 mg/day)
干预措施: Levofloxacin (Drug)
Group B: Placebo
Receiving oral placebo at the same dosage as the treatment group.
干预措施: Placebo (Other)
结局指标
主要结局
Median time to first febrile neutropenia
时间窗: First febrile neutropenia up to day 63
The number of participants with first febrile neutropenia and the median day of occurrence.
Clinical Outcome
时间窗: First febrile neutropenia up to day 63
The number of participants who experienced fever, first febrile neutropenia, severe infection, organ-related infection, microbiologically confirmed infection, infection-related mortality
次要结局
- Caused of mortality(up to 12 weeks)
- Patients with positive cultures(up to 12 weeks)
研究者
Idha Yulandari
Principal Investigator
Gadjah Mada University