Informations générales (source: ClinicalTrials.gov)

NCT03450512 En recrutement
Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy (DECLAM).
Observational
  • Entérocolite
  • Leucémies
  • Leucémie myéloïde
  • Leucémie aigüe myéloïde
  • Entérocolite du patient neutropénique
Centre Hospitalier Universitaire, Amiens (Voir sur ClinicalTrials)
janvier 2019
novembre 2024
12 septembre 2025
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.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU de Caen - 14033 - Caen - France Sylvain CHANTEPIE, PhD Recrutement non commencé Contact (sur clinicalTrials)
Henri Becquerel Center - 76038 - Rouen - France Fabrince JARDIN, PhD En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Amiens-Picardie - 80000 - Amiens - France Delphine LEBON, Ph Recrutement non commencé Contact (sur clinicalTrials)

Critères

Tous
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



- 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)