NCT04438278Unknown不适用
Neutropenic Enterocolitis in Critically Ill Hematological Patients: Taxonomic and Functional Analysis of Gut Microbiota
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Shannon index of α-diversity
研究概览
简要总结
A prospective, single-center, cohort study to allow collecting observations of patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML), collecting biological samples(including fecal samples for microbiota analyses, and metagenomic profiling in blood samples) and clinical outcomes (notably the occurrence of neutropenic enterocolitis), with a nested case-control analysis comparing patients with or without neutropenic enterocolitis
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •patient>= 18 years old;
- •cytological diagnosis of de novo Acute Myeloid Leukemia (AML) (>20% myeloid blasts);
- •eligible for intensive chemotherapy (no severe co-morbidity);
- •not having received any prior chemotherapy;
- •affiliation to the national social security system.
排除标准
- •acute promyelocytic leukemia (AML 3);
- •inability to understand the nature of investigations or to give informed non-opposition;
- •person subject to a legal protection measure.
结局指标
主要结局
Shannon index of α-diversity
时间窗: At day 1, before chemotherapy initiation
Shannon index of α-diversity assessed by shotgun metagenomic analysis of the stool
次要结局
- Occurrence of any local neutropenic enterocolitis complications(60 days)
- Fecal microbiota's profile(At day 14)
- Intensive Care Unit (ICU) - mortality(60 days)
- Biodiversity in microbiota(Day 1, day 14, day 28, day 42)
- Hospital - mortality(60 days)
- 1-year mortality(1 year)
- Occurrence of malnutrition in patients with severe neutropenic enterocolitis(60 days)
- Occurrence of microbiologically documented infections in patients with severe neutropenic enterocolitis(60 days)
- Whole-blood metatranscriptomic profile evolution(Day 1, day 14, day 28, day 42)
研究者
研究点 (1)
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