Profile Fecal Analysis of Neutropenic Enterocolitis

Assistance Publique - Hôpitaux de Paris200 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Neutropenic Enterocolitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

AP-HP Hôpital Saint Louis

Paris, France

RECRUITING

Outcomes

Primary Outcomes

Shannon index of α-diversity

Shannon index of α-diversity assessed by shotgun metagenomic analysis of the stool

Time frame: At day 1, before chemotherapy initiation

Secondary Outcomes

Fecal microbiota's profile

Taxonomic identification in shotgun metagenomic

Time frame: At day 14

Intensive Care Unit (ICU) - mortality

Death while hospitalized in the intensive care unit

Time frame: 60 days

Hospital - mortality

Death while hospitalized

Time frame: 60 days

1-year mortality

Death within 1 year of inclusion

Time frame: 1 year

Occurrence of any local neutropenic enterocolitis complications

Local neutropenic enterocolitis complications defined as perforation or digestive hemorrhage or abscess

Time frame: 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

Time frame: 60 days

Occurrence of malnutrition in patients with severe neutropenic enterocolitis

Malnutrition defined by the European Society of Clinical nutrition and Metabolism

Central Contacts

Lara Zafrani, MD PhD

CONTACT

+33 1 42 49 49 49 lara.zafrani@aphp.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.