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NCT Number: NCT06797648

Epidemiology of Infection in Acute Myeloid Leukemia (AML)

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli Irccs, Uoc Ematologia

Rome, 00168, Italy

Location contact

LIVIO PAGANO, PROF

CONTACT

[email protected]

+390630155530

LIVIO PAGANO, PROF

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Data analysis

Other

follow up after 15 months

Primary outcomes

Incidence of bacterial/fungal/viral infections in AML patients

Time frame: 18 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

LIVIO PAGANO

CONTACT

[email protected]

+390630155530

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Epidemiology of Infection in AML, A European Haematology Association Survey

Acronym: EPIAMLINF

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2029
First posted: Jan 28, 2025
Registry last updated: Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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