Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Alterations to microbiome diversity in children treated with rifaximin compared to the historical cohort.
研究概览
简要总结
Primary purpose of the study is to see if rifaximin can improve the balance of bacteria within the gut, which has been shown to improve transplant outcomes. It will also assess whether rifaximin can reduce the risk of infection in blood/marrow transplant (BMT).
详细描述
This study is for patients who will be having a blood/marrow transplant (BMT) to treat leukemia, lymphoma or other cancer of the blood. The blood or marrow cells will come from another person (donor)-allogeneic BMT. Bacterial infections and acute graft versus host disease (AGVHD) are frequent complications of allogeneic BMT. Bacterial infections sometimes happen because injury to the gut during transplant allows gut bacteria to cross the injured gut barrier and get to the blood. AGVHD happens when certain white blood cells, called T-cells, in the donor cells (the graft) attack the patient's body.
Primary purpose of the study is to see if rifaximin can improve the balance of bacteria within the gut, which has been shown to improve transplant outcomes. It will also assess whether rifaximin can reduce the risk of infection in blood/marrow transplant (BMT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allogeneic HSCT recipients between the ages of 2 and 21 years.
- •Underlying hematologic malignancy, regardless of donor type or graft source.
- •Myeloablative conditioning regimen.
排除标准
- •Known hypersensitivity to rifaximin, or other rifamycin antimicrobial agents.
- •Minimally toxic conditioning regimen (e.g. low dose TBI based). Since these regimens induce minimal myelosuppression and gut injury, patients receiving them probably stand little to gain from antibiotic prophylaxis.
- •Patients with ongoing bacterial, viral or fungal active infections are not eligible for this study. Patients who remain on broad spectrum antibiotics for the treatment of a previous infection are not eligible.
- •The use of prophylactic antibiotics is not permitted.
- •Following the standard practice in blood and marrow transplantation, pregnant or breast feeding patients will be excluded
研究组 & 干预措施
Rifaximin
Rifaximin will be administered twice a day orally or by nasogastric tube to patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
干预措施: Rifaximin (Drug)
结局指标
主要结局
Alterations to microbiome diversity in children treated with rifaximin compared to the historical cohort.
时间窗: Period between the start of the preparative regimen and day 28 post transplant
Composition will be assessed using 16S RNA sequencing. The Shannon index will be calculated for quantification of bacterial diversity.
次要结局
- Number of patients with Acute GVHD(Period between the start of the preparative regimen and day 100 post transplant)
- Number of patients with Chronic GVHD including overlap syndrome(Period between the start of the preparative regimen and year 5 post-transplant.)
- Number of patients with other Infections(Period between the start of the preparative regimen and day 28 post transplant)
- Number of patients with relapse free survival at 1 year(Period between the start of the preparative regimen and year 1 post-transplant.)
- Overall number of patients survived at 1 year(Period between the start of the preparative regimen and year 1 post-transplant.)
- Rates of BSI pathogen infection/colonization frequency during the treatment period compared to the historical cohort.(Period between the start of the preparative regimen and day 28 post transplant)
- Transplant related mortality (TRM)(Period between the start of the preparative regimen and day 28 post transplant)
研究者
Muna Qayed
Associate Professor
Emory University