Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy (DECLAM)

Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy (DECLAM).

Neutropenia after induction or consolidation therapy for acute myeloid leukemia (AML) patients is associated with a high morbi-mortality rates, especially due to infectious complications. These are managed according to international recommandations (ECIL and IDSA) with antibiotherapy and antifungal strategy. Although the patients suffer of digestive symptoms, intestinale complications are really less explored. Neutropenic enterocolitis (NE), cytomegalovirus (CMV) colitis, Clostridium difficile colitis, specific lesion, ischemic colitis are not well-known. No prospective study evaluate NE and these digestive complications which have high morbi-mortality rates.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: prospective study on digestive affections in an homogeneous cohort of hematological patients

Detailed Description

This is the first prospective study on digestive affections in an homogeneous cohort of hematological patients. These affections are unknown in neutropenic patients with digestive symptoms after induction or consolidation courses pour AML although causing high morbi-mortality rates (infections, denutrition, loss of autonomy…).

The aim of the study is to evaluate incidence of NE by clinical signs and with a systematic CT scan performed at day 5 of fever during aplastic period. An early diagnostic could decrease complications and evaluate gravity criteria which could imply surgery therapy.

The physician will performe a CTscan with injection during the induction and/or every consolidation, at the same time as the thoracic CTscan (to research an invasive fungal bronchopulmonary infection), in front of a febrile neutropenia with persistent fever after 5 days of antibiotics and presence of digestive signs.

The clinical, microbiological, radiological symptoms will be registered at every time of febrile neutropenia with digestive symptoms at induction and each consolidation courses. The patient will be get out of the study when the AML is refractory, hematopoietic stem cell transplantation is required or if whenever he want. The last visit will be at the end of consolidation courses.

• Study Type: Observational
• Enrollment (Estimated): 170

Contacts and Locations

• Study Contact: Name: Delphine LEBON, Doctor; Phone Number: 0033 3 22 45 59 17; Email: lebon.delphine@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80000
    • Not yet recruiting
    • CHU Amiens-Picardie
    • Contact: Delphine LEBON, Ph; Email: lebon.delphine@chu-amiens.fr
    • Principal Investigator: Delphine LEBON, Ph
  • Caen, France, 14033
    • Not yet recruiting
    • CHU de CAEN
    • Contact: Sylvain CHANTEPIE, PhD
    • Principal Investigator: Sylvain CHANTEPIE, PhD
  • Rouen, France, 76038
    • Recruiting
    • Henri Becquerel Center
    • Contact: Fabrince JARDIN, PhD
    • Principal Investigator: Fabrice JARDIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with febrile neutropenia after induction or consolidation courses for AML( acute myeloid leukemia ).

Description

Inclusion Criteria:

• Age > 18 years
• inclusion criteria:

Every patient of hematology:

• Able to receive an intensive treatment for AML (induction then intensive consolidations) causing a neutropenia with high infectious risk
• In state to give its consent
• Affiliated to a social security system

Exclusion Criteria:

• The minor patients
• The patients affected by AML not being able to receive an intensive therapy
• The patients affected by acute promyelocytic leukaemia
• The pregnant women
• The patients with HIV, hepatitis B or C
• The patients under guardianship or guardianship or deprived of freedom by a court or administrative order (according to articles L1121-6 and L1121-8 of the Public health code)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the arisen of EC in the CT scan	The main assessment criteria is the arisen of EC in the CT scan with injection realized at day 5 of fever under antibiotics for every inclusive patient, with febrile neutropenia, and presenting digestive symptoms during the period of aplasie post-chemotherapy after exclusion from the other diagnosis (infectious colitis and other abdominal syndromes).	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Estimated): November 11, 2024
• Study Completion (Estimated): November 13, 2024

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Acute myeloid leukemia; Neutropenic enterocolitis; Abdominal tomodensitometry
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Enterocolitis; Enterocolitis, Neutropenic
• Other Study ID Numbers: PI2017_843_0031

Drug and device information, study documents

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