NCT03450512 Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy
| 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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 170 participants in total. It began in 2019-01-14 with a primary completion date of 2024-11-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03450512 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03450512 currently recruiting?
Yes, NCT03450512 is actively recruiting participants. Contact the research team at lebon.delphine@chu-amiens.fr for enrollment information.
Where is the NCT03450512 trial being conducted?
This trial is being conducted at Amiens, France, Caen, France, Rouen, France.
Who is sponsoring the NCT03450512 clinical trial?
NCT03450512 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 170 participants.
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