Clinical trial NCT06797648: Epidemiology of Infection in Acute Myeloid Leukemia (AML)
Official title: Epidemiology of Infection in AML, A European Haematology Association Survey
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Myeloid Leukemia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population must be ≥18 years of age with a new diagnosis AML and microbiologically/clinically documented bacterial/fungal/viral infection. Patients with fever of unidentified origin (FUO) could be included. In order to obtain a denominator for all cases of AML, it is required to fill out the eCRF. The form must be filled out for each phase of treatment (i.e. induction, consolidation, relapsed, refractory). Patients stop recording when they go to HSCT.

Brief summary: 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.


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)

Primary outcomes:
measure: Incidence of bacterial/fungal/viral infections in AML patients
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli Irccs, Uoc Ematologia
Study officials:
affiliation: FONDAZIONE POLICLINICO GEMELLI, IRCCS
name: LIVIO PAGANO, PROF
role: PRINCIPAL_INVESTIGATOR
References: