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Starting soon Observational

Epidemiology of Infection in Acute Myeloid Leukemia (AML)

NCT06797648 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-03-01
Last updated
2025-01-28

Condition(s) studied

Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

data analysis

data analysis: follow up after 15 months

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Incidence of bacterial/fungal/viral infections in AML patients — 18 months
    To evaluate the incidence of bacterial/fungal/viral infections in AML patients undergoing induction, consolidation or salvage chemotherapy.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli Irccs, Uoc Ematologia Rome Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06797648 on ClinicalTrials.gov ↗ ← All trials in Italy