NCT07113314已完成不适用
Phase II Study for Prophylaxis of Febrile Neutropenia by Supplementation With Lactoferrin in Oncohematologic Children Undergoing High-intensity Chemotherapy Treatment
Fondazione IRCCS Policlinico San Matteo di Pavia2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2016年10月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Primary Outcome
研究概览
简要总结
Test, in a randomized phase II trial, the safety and efficacy of lactoferrin prophylaxis in preventing the occurrence of febrile neutropenia and sepsis, with particular regard to forms due to multidrug-resistant Gram-negative bacteria.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe neutropenia lasting >7 days:
- •non-High Risk Acute Lymphoblastic Leukemia ( ALL) under induction treatment
- •Acute Myeloid Leukemia (AML) (first two cycles of treatment)
- •B cell - non Hodgkin Lymphoma (NHL) Ability to take oral lactoferrin therapy and perform the diagnostic tests established by the protocol
排除标准
- •Previous chemotherapy treatments
- •Past history of colonization/infection by multidrug-resistant pathogens
- •Inability to take LF by mouth
- •Refusal to participate in the study
结局指标
主要结局
Primary Outcome
时间窗: From treatment up to 90 days
Presence or absence of febrile neutropenia or sepsis
次要结局
未报告次要终点
研究者
Marco Zecca
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
研究点 (2)
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