Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors: Impact on Intestinal Microbiota and in Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 5
- 主要终点
- Impact on microbiota
研究概览
简要总结
There are data suggesting that the reduction of the diversity of intestinal microbiota caused by the used treatments in the setting of allogeneic hemopoietic stem cell transplant (ASCT), and specially antibiotics, may be related to increased incidence of graft versus host disease (GVHD) and worst clinical outcomes. Present "European Conference on Infections in Leukaemia" guidelines exhort to antibiotic treatment optimization in hematological patients, without excluding ASCT receptors. This study aims to demonstrate that in ASCT receptors a predefined protocol of optimization of the antibacterial treatment will preserve the intestinal microbiota diversity which will correlate with decrease incidence of acute GVHD. And that this procedure is safe because it will not worsen the incidence of infections, transplant related mortality, infectious mortality or global survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients admitted to receive their first allogeneic hematopoietic transplant as a treatment of any disease.
- •Conformity of the patient to participate by signing the informed consent.
- •Patients who have received a previous autologous transplant are not excluded.
排除标准
- •Non-compliance of the patient to sign the informed consent.
- •Patients who have already started the conditioning (or thereafter) will not be included.
- •Allograft recipients who have previously received the transplant will not be included. Second allogeneic transplants are excluded.
结局指标
主要结局
Impact on microbiota
时间窗: From the Previous Day of starting conditioning treatment until the last documented day of antibiotherapy or hospital discharge, whichever came first, assessed up to one month post-transplant.
Comparison of biological alpha and beta diversity of the intestinal microbiota of both study groups (classical and optimized antibiotherapy). Calculation of alpha diversity (OTUs richness and Shannon diversity indexes observed, Faith's Phylogenetic Diversity and Evenness) and beta diversity (Jaccard distance, Bray-Curtis distance, Unweighted UniFra distance, used for comparing biological communities) indexes by QIIME 2 (microbiome bioinformatics platform).
次要结局
- Transplant related mortality(From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant)
- Incidence of severe infections(From the day of transplant (Day 0) to Day +30 posttransplant)
- Overall survival(From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant)
- Incidence of Acute graft versus host disease(From the day of transplant (Day 0) to Day +100 posttransplant)
- Disease free survival(From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant)
- Mortality caused by infection(From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant)