Epidemiology of Infection in Acute Myeloid Leukemia (AML) (EPIAMLINF)

Epidemiology of Infection in AML, A European Haematology Association Survey

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: data analysis

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: LIVIO PAGANO; Phone Number: +390630155530; Email: LIVIO.PAGANO@POLICLINICOGEMELLI.IT

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli Irccs, Uoc Ematologia
    • Contact: LIVIO PAGANO, PROF; Phone Number: +390630155530; Email: LIVIO.PAGANO@POLICLINICOGEMELLI.IT
    • Principal Investigator: LIVIO PAGANO, PROF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bacterial/fungal/viral infections in AML patients	To evaluate the incidence of bacterial/fungal/viral infections in AML patients undergoing induction, consolidation or salvage chemotherapy.	18 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: LIVIO PAGANO, PROF, Fondazione Policlinico Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 7283

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No