Profile Fecal Analysis of Neutropenic Enterocolitis

Neutropenic Enterocolitis Clinical Trial

— PROFANE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04438278
• Other study ID #: APHP190826
• Status: Recruiting
• Start date: July 8, 2020
• Est. completion date: July 2023

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Lara Zafrani, MD PhD
• Phone: +33 1 42 49 49 49
• Email: lara.zafrani[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2023
• Est. primary completion date: July 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enterocolitis
• Neutropenic Enterocolitis

Locations

Country	Name	City	State
France	AP-HP Hôpital Saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shannon index of a-diversity	Shannon index of a-diversity assessed by shotgun metagenomic analysis of the stool	At day 1, before chemotherapy initiation
Secondary	Fecal microbiota's profile	Taxonomic identification in shotgun metagenomic	At day 14
Secondary	Intensive Care Unit (ICU) - mortality	Death while hospitalized in the intensive care unit	60 days
Secondary	Hospital - mortality	Death while hospitalized	60 days
Secondary	1-year mortality	Death within 1 year of inclusion	1 year
Secondary	Occurrence of any local neutropenic enterocolitis complications	Local neutropenic enterocolitis complications defined as perforation or digestive hemorrhage or abscess	60 days
Secondary	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
Secondary	Occurrence of malnutrition in patients with severe neutropenic enterocolitis	Malnutrition defined by the European Society of Clinical nutrition and Metabolism	60 days
Secondary	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
Secondary	Whole-blood metatranscriptomic profile evolution	Identification of clusters of gene expression	Day 1, day 14, day 28, day 42