Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: a Randomized Controlled Study -DALFEN Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Treatment is considered to be successful if the following is attained without changing the regimen - Patient remains afebrile till recovery of ANC ≥500 •Measure of effect: Proportion of patients afebrile in each arm
研究概览
简要总结
Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with low risk features (culture awaited), will be started on intravenous antibiotics (Inj Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Those patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. Antibiotics will be stopped in Arm-A and oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B. The patients will be followed-up till ANC≥ 500, or reappearance of fever within follow-up of ≤ 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pediatric febrile neutropenia patients treated on outpatient basis
- •Age 3 years - 18 years
- •Fulfilling low risk criteria ( Hematological malignancies in remission, No identifiable focus of infection, No Pneumonia/ mucositis / GI sepsis / Nausea-vomiting/ neurologic-mental status changes/ Central Venous Catheter (CVC) related infection, Anticipated Absolute Neutrophil Count (ANC) recovery ≤ 10 days, No organ dysfunction, Hemodynamically stable, Culture negative )
- •Afebrile for at least 24 hours, on intra-venous antibiotics
排除标准
- •Bone marrow involvement in solid tumor
- •Already enrolled once, in previous episode
- •On antibiotics prophylaxis
- •Retroviral positive patients
- •Patient undergone stem cell transplant
研究组 & 干预措施
arm (B) - oral antibiotics till ANC ≥ 500
patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B.
干预措施: levofloxacin (Other)
arm (A) - stoppage of antibiotics
patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. Antibiotics will be stopped in Arm-A.
干预措施: stoppage of antibiotics (Other)
arm (B) - oral antibiotics till ANC ≥ 500
patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B.
干预措施: amoxycillin/clavulanic acid (Other)
结局指标
主要结局
Treatment is considered to be successful if the following is attained without changing the regimen - Patient remains afebrile till recovery of ANC ≥500 •Measure of effect: Proportion of patients afebrile in each arm
时间窗: till ANC ≥ 500 or reappearance of fever during the period ≤ 10 days
次要结局
- Rate of re-admission(till ANC ≥ 500 or reappearance of fever during the period ≤10 days)
研究者
AKASH KUMAR
Senior Resident (DM course)
All India Institute of Medical Sciences, New Delhi