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Recruiting NCT03450512

NCT03450512 Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy

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Clinical Trial Summary
NCT ID NCT03450512
Status Recruiting
Phase
Sponsor Centre Hospitalier Universitaire, Amiens
Condition Acute Myeloid Leukemia
Study Type OBSERVATIONAL
Enrollment 170 participants
Start Date 2019-01-14
Primary Completion 2024-11-11

Trial Parameters

Condition Acute Myeloid Leukemia
Sponsor Centre Hospitalier Universitaire, Amiens
Study Type OBSERVATIONAL
Phase N/A
Enrollment 170
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2019-01-14
Completion 2024-11-11
Interventions
prospective study on digestive affections in an homogeneous cohort of hematological patients

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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.

Eligibility Criteria

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)

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