Profile Fecal Analysis of Neutropenic Enterocolitis

Study Overview
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Brief Summary
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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

Official Title
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Neutropenic Enterocolitis in Critically Ill Hematological Patients: Taxonomic and Functional Analysis of Gut Microbiota

Conditions
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Neutropenic Enterocolitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shannon index of α-diversity | Shannon index of α-diversity assessed by shotgun metagenomic analysis of the stool | At day 1, before chemotherapy initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal microbiota's profile | Taxonomic identification in shotgun metagenomic | At day 14 | 
| Intensive Care Unit (ICU) - mortality | Death while hospitalized in the intensive care unit | 60 days | 
| Hospital - mortality | Death while hospitalized | 60 days | 
| 1-year mortality | Death within 1 year of inclusion | 1 year | 
| Occurrence of any local neutropenic enterocolitis complications | Local neutropenic enterocolitis complications defined as perforation or digestive hemorrhage or abscess | 60 days | 
| Occurrence of microbiologically documented infections in patients with severe neutropenic enterocolitis | Microbiologically documented infections defined as pneumonia, invasive device infections, urinary tract infections, digestive or neuro-meningitis infections | 60 days | 
| Occurrence of malnutrition in patients with severe neutropenic enterocolitis | Malnutrition defined by the European Society of Clinical nutrition and Metabolism | 60 days | 
| Biodiversity in microbiota | Analysis of alpha and beta-diversity in fecal samples from day 0 to day 60 | Day 1, day 14, day 28, day 42 | 
| Whole-blood metatranscriptomic profile evolution | Identification of clusters of gene expression | Day 1, day 14, day 28, day 42 |