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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia Other: prospective study on digestive affections in an homogeneous cohort of hematological patients

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.


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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Case-Only
Time Perspective: Prospective
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



Intervention Details:
  • 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.



Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with febrile neutropenia after induction or consolidation courses for AML( acute myeloid leukemia ).
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Delphine LEBON, Doctor 0033 3 22 45 59 17 lebon.delphine@chu-amiens.fr

Locations
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France
CHU Amiens-Picardie Not yet recruiting
Amiens, France, 80000
Contact: Delphine LEBON, Ph       lebon.delphine@chu-amiens.fr   
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03450512     History of Changes
Other Study ID Numbers: PI2017_843_0031
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Neutropenic enterocolitis
Acute myeloid leukemia
Abdominal tomodensitometry
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Enterocolitis
Enterocolitis, Neutropenic
Neoplasms by Histologic Type
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases