Epidemiology of Infection in Acute Myeloid Leukemia (AML)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: data analysis.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Epidemiology of Infection in AML, A European Haematology Association Survey
Overview
In recent years, multiple factors have strongly impacted the epidemiology of infections in patients with acute myeloid leukemia. On the one hand, the availability of new effective antileukemic drugs (i.e. venetoclax, FLT-3 inhibitors, CPX-351) have expanded the pharmacological armamentarium. On the other hand, first, many of them inhere drug-drug interactions with azoles and fluoroquinolones, facing clinicians with the choice of whether to administer antimicrobial prophylaxis or not. Secondly, there is an increase in infections due to multi-resistant agents from both the bacterial and fungal field. Third, the onset of a viral pandemic that had high relevance in these patients in terms of morbidity and mortality. The aim of this survey is to collect information on the largest possible sample of patients with AML during induction/consolidation/relapsed-refractory treatment, regarding bacterial, viral, fungal infections. We will evaluate the incidence of the various types of infection in relation to the type of treatment that patients will undergo, in order to identify what should be the best antimicrobial prophylactic approach in each subset of patients.
Interventions
- Other data analysis
follow up after 15 months
Primary outcome measures
- Incidence of bacterial/fungal/viral infections in AML patients [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
- Ability to sign the consent form
- Age ≥18 years
- New diagnosis of AML (only cases diagnosed after 01/03/2025), APL are included
- Patients not elegible to any kind of chemotherapy but only best supportive care (BSC)
- AML patients treated with induction treatment, consolidation treatment, or relapsed/refractory (for these latter patients the first diagnosis must not be prior to March 01, 2025)
- All kind of infectious diseases, including parasites.
- Clincally or microbiologically diagnosed infections, including FUO
Exclusion criteria
- Hematological diseases, other than AML
- Patients with an AML diagnosis prior to March 2025 but who relapsed during the period under examination
- Patients relapsed after allo or auto-HSCT (Inclusion of post-transplant patients would create an evaluation bias due to the immunological alterations that the transplant procedure causes)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli Irccs, Uoc Ematologia — Rome
Identifiers
NCT: NCT06797648 · 7283