Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy (DECLAM)
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|ClinicalTrials.gov Identifier: NCT03450512|
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment|
|Acute Myeloid Leukemia||Other: prospective study on digestive affections in an homogeneous cohort of hematological patients|
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|
|Estimated Enrollment :||170 participants|
|Official Title:||Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy (DECLAM).|
|Actual Study Start Date :||January 14, 2019|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2022|
- Other: prospective study on digestive affections in an homogeneous cohort of hematological patients
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.
- the arisen of EC in the CT scan [ Time Frame: 1 day ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450512
|Contact: Delphine LEBON, Doctor||0033 3 22 45 59 email@example.com|
|CHU Amiens-Picardie||Not yet recruiting|
|Amiens, France, 80000|
|Contact: Delphine LEBON, Ph firstname.lastname@example.org|
|Principal Investigator: Delphine LEBON, Ph|
|CHU de Caen||Not yet recruiting|
|Caen, France, 14033|
|Contact: Sylvain CHANTEPIE, PhD|
|Principal Investigator: Sylvain CHANTEPIE, PhD|
|Henri Becquerel Center||Recruiting|
|Rouen, France, 76038|
|Contact: Fabrince JARDIN, PhD|
|Principal Investigator: Fabrice JARDIN|