Profile Fecal Analysis of Neutropenic Enterocolitis (PROFANE)

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

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 Overview

• Status: Recruiting
• Conditions: Neutropenic Enterocolitis

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Lara Zafrani, MD PhD; Phone Number: +33 1 42 49 49 49; Email: lara.zafrani@aphp.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • AP-HP Hôpital Saint Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML)

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 8, 2020
• Primary Completion (ANTICIPATED): July 8, 2022
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (ACTUAL): June 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Enterocolitis; Enterocolitis, Neutropenic
• Other Study ID Numbers: APHP190826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No