Randomized, Double Blinded, Placebo-Controlled Trial of Antibacterial Prophylaxis for the Prevention of Bacterial Infections in the Post-Engraftment Phase After Allogeneic Hematopoeitic Stem Cell Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
RATIONALE: A donor stem cell transplant can lower the body's immune system, making it difficult to fight off infection. Giving antibiotics, such as moxifloxacin, may help prevent bacterial infections in patients who have recently undergone donor stem cell transplant. It is not yet known whether moxifloxacin is more effective than a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant.
PURPOSE: This randomized phase III trial is studying moxifloxacin to see how well it works compared with a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant.
详细描述
OBJECTIVES:
Primary
- Assess the safety and tolerability of giving prophylactic moxifloxacin hydrochloride during the post-engraftment phase in patients who have undergone allogeneic stem cell transplantation. (Pilot study)
- Compare the efficacy, in terms of reducing the incidence of clinically and microbiologically documented bacterial infections, in patients who have undergone allogeneic stem cell transplantation treated with prophylactic moxifloxacin hydrochloride vs placebo during the post-engraftment phase. (Phase III)
Secondary
- Determine the incidence of clinically and microbiologically documented bacterial infections in these patients. (Pilot study)
- Assess the impact of moxifloxacin hydrochloride on the incidence of bacteremia in these patients. (Phase III)
- Compare the percentage of time on systemic antibiotics and days hospitalized in patients treated with these regimens. (Phase III)
- Compare the incidence of veno-occlusive disease of the liver in patients treated with these regimens. (Phase III)
- Compare the incidence and severity of graft-versus-host disease in patients treated with these regimens. (Phase III)
- Compare the infection-related mortality and overall mortality of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 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
moxifloxacin hydrochloride
Moxifloxacin 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
干预措施: moxifloxacin hydrochloride (Drug)
Sugar pill
Placebo 1 capsule orally once a day through D+100 after bone marrow transplant, then discontinue
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 1 to 120 days post bone marrow transplant
次要结局
- Incidence and severity of graft-versus-host disease(1 to 120 days post bone marrow transplant)
- Incidence of bacteremia(1 to 120 days post bone marrow transplant)
- Infection-related mortality(1 to 120 days post bone marrow transplant)
- Overall mortality(1 to 120 days post bone marrow transplant)
研究者
Joseph Bubalo
PharmD
OHSU Knight Cancer Institute