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

NCT03450512 | Recruiting

• 1 other identifier: PI2017_843_0031
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Acute Myeloid Leukemia

Keywords

Neutropenic enterocolitis; Acute myeloid leukemia; Abdominal tomodensitometry

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

prospective study on digestive affections in an homogeneous cohort of hematological patients OTHER

Systematic realization during the induction and/or every consolidation of a CTscan with injection, 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. Statement of the information characterizing the digestive affection: clinical symptoms, microbiological, characteristic, realized additional explorations, infectious complications and specific therapeutics. The abdominal scanner will be repeated in case of suspicion of complication or clinical worsening. In case of EC, the abdominal scanner will be realized before beginning the next cycle of AML treatment to evaluate digestive remission. Finally, a CT scan, will be performed when digestive disease, digestive neoplasia or digestive symptoms are noted at AML diagnosis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age \> 18 years
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (3)

CHU Amiens-Picardie

Amiens, 80000, France

NOT YET RECRUITING

CHU de Caen

Caen, 14033, France

NOT YET RECRUITING

Henri Becquerel Center

Rouen, 76038, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Enterocolitis, Neutropenic

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Delphine LEBON, Doctor

CONTACT

0033 3 22 45 59 17; lebon.delphine@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: March 1, 2018
• Study Start: January 14, 2019
• Primary Completion: November 11, 2024
• Study Completion: November 13, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

FR (3)