Phase II Open Label Pilot Trial of Empiric Daptomycin Treatment for Oncology Patients With Neutropenic Fever
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.
研究概览
简要总结
RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in patients with cancer.
PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer.
详细描述
OBJECTIVES:
Primary
- Assess the response rate to therapy within 72 hours of starting daptomycin in cancer patients with neutropenic fever.
Secondary
- Assess the percentage of bacterial cures in patients with documented gram-positive bacterial infections.
- Assess time to afebrile state.
- Assess the pharmacokinetic data of daptomycin in neutropenic patients.
- Document the incidence of breakthrough infections that require a change of therapy or additional agents to clear.
- Assess the tolerability of daptomycin in neutropenic patients.
- Assess and document adverse events and toxicity due to daptomycin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Daptomycin
干预措施: Daptomycin (Drug)
结局指标
主要结局
Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.
时间窗: Within 72 hours of starting daptomycin
If after 72 hours of daptomycin treatment, the patient is afebrile and has absolute neutrophil count (ANC) \>500 cells/mm\^3 for 48 hours with no site of infection, negative cultures, and no clinical indications for therapy, the antibiotic regimen will be discontinued. Complete Response: Resolution of fever and clinical signs/symptoms of infection. Partial Response: Resolution of fever without resolution of clinical signs of infection.
次要结局
未报告次要终点
研究者
Joseph Bubalo
PharmD
OHSU Knight Cancer Institute