Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia: Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever
研究概览
简要总结
The purpose of this study is to determine whether short-course antibiotic therapy is safe and effective for the treatment of cancer patients with febrile neutropenia.
详细描述
Febrile neutropenia remains a major cause of morbidity in solid cancer patients. There is an unresolved question regarding the appropriate duration of antibiotic treatment for patients with febrile neutropenia of unknown origin. Current guidelines recommend at least seven days of antibiotic treatment. Several studies have demonstrated the safety of early antibiotic discontinuation in patients with febrile neutropenia. We plan an open label randomized controlled trial to compare early antibiotic discontinuation to the accepted prolonged antibiotic treatment protocol
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >18 years providing signed informed consent
- •Patients with solid tumors, lymphoma, multiple myeloma or chronic lymphocytic leukemia, regardless of disease status or previous chemotherapy
- •Documented febrile neutropenia
- •No clinically or microbiologically documented infection after 72 hours
排除标准
- •Previous enrollment in this study
- •Concurrent participation in another interventional trial
- •Severe sepsis or septic shock
- •Acute leukemia, autologous or allogeneic hematopoietic stem-cell transplantation
- •Diarrhea suspected by treating physician to be Irinotecan induced
- •Any antibiotic treatment for >48h in the last week before enrollment
结局指标
主要结局
Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever
时间窗: After day 7 from randomization until day 30
Composite outcome of all-cause mortality, severe infection (defined as clinically or microbiologically documented infection with systemic inflammatory response syndrome (SIRS)), severe diarrhea (\>=3 daily for \>=2 days) or fever (\>38)
Total febrile or antibiotic days
时间窗: From the day of randomization until day 30
Total febrile or antibiotic days from the day of randomization until day 30, defined as a day with one or more temperature measurement \>38.0°C or a day on which antibiotic treatment was prescribed for any reason other than prophylaxis
次要结局
- Clinically and/or microbiologically documented infections(30 days)
- Total in-hospital days(30 days)
- Re-admission(30 days)
- Antibiotic treatment(After day 7 from randomization until day 30)
- Antifungal treatment(30 days)
- Duration of intravenous antibiotic treatment(30 days)
- Duration of neutropenia(30 days)
- Development of resistance(30 days)
- All-cause mortality(30 days)
- Infection-related mortality(30 days after randomization)
研究者
leibovici leonard
Professor
Rabin Medical Center