A Randomized, Double-Blind Trial Comparing Linezolid To Vancomycin In The Empiric Treatment Of Febrile Neutropenic Oncology Patients With Suspected Gram-Positive Infections
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical efficacy of linezolid when administered intravenously as compared to intravenously administered vancomycin in the empiric treatment of oncology patients with febrile neutropenia with suspected gram-positive infections.
研究概览
简要总结
This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have neutropenia (ANC less than 500) with fever (oral temp 38.3 C).
- •Patients must have a cancer with recent chemotherapy and risks factors for gram positive infections.
排除标准
- •Patients with fever due to known causes. Patients with HIV. Patients with recent bone marrow transplant. Patients with an infected indwelling catheter that cannot be removed. Patients who have received more than one day of another antibiotic before entering the trial.
- •Patients with endocarditis, osteomyelitis, meningitis, CNS infections.
研究组 & 干预措施
A.
Patients will be stratified according to the use of prophylactic antibiotics. Both groups may receive open-label gram-negative coverage with either ceftazidime, aztreonam, and/or aminoglycosides (gentamicin, tobramycin, amikacin). Subjects will receive study medication intravenously every 12 hours for 7 to 28 days.
干预措施: linezolid (Drug)
B.
干预措施: vancomycin (Drug)
结局指标
主要结局
Clinical efficacy of linezolid when administered intravenously as compared to intravenously administered vancomycin in the empiric treatment of oncology patients with febrile neutropenia with suspected gram-positive infections.
时间窗: 7-28 days
次要结局
- Time to defervescence(7-28 days)
- Time to resolution of neutropenia(7-28 days)
- Mortality rate (survival at 7 days after the end of therapy)(7-28 days)
- Microbiologic outcome(7-28 days)
- Pathogen eradication (eradication rates of individual pathogens)(7-28 days)
- Defervescence (defined as Tmax orally or rectally)(7-28 days)
- Resolution of neutropenia (return of ANC to >500 cells/mm3)(7-28 days)