Etude : DECLAM /

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Type d'étude
Présentation de l'étude
Acronyme : DECLAM

Nom :

Traitement :

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 24/01/2020
CIM10 - Localisation(s)
Informations principales
Titre : Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C92 - Leucémie myéloïde
Informations complémentaires
Schéma : 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

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.

Phase : NA

Stade : NA

Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : 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

Critères de non-inclusion : 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)
Informations relatives au promoteur
Promoteur :
CHU Amiens-Picardie
Type de sponsor : Institutionnel
CHU Amiens-Picardie
80000 AMIENS

Coordonnateur :
Delphine LEBON
+33 3 22 45 59 17
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre Henri Becquerel - Rue d'Amiens CS 11516 - Cedex 1 - 76000 ROUEN

Investigateur :

Sandrine VAUDAUX

Statut de l'essai : OUVERT

MAJ : 24/01/2020