Epidemiology of Infection in Acute Myeloid Leukemia (AML)

NCT ID: NCT06797648

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2029-06-30

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

data analysis

follow up after 15 months

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LIVIO PAGANO, PROF

Role: PRINCIPAL_INVESTIGATOR

FONDAZIONE POLICLINICO GEMELLI, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli Irccs, Uoc Ematologia

Rome, , Italy

Countries

Italy

Central Contacts

LIVIO PAGANO

Role: CONTACT

LIVIO.PAGANO@POLICLINICOGEMELLI.IT

+390630155530

Facility Contacts

LIVIO PAGANO, PROF

Role: primary

LIVIO.PAGANO@POLICLINICOGEMELLI.IT

+390630155530

Other Identifiers

7283

Identifier Type: -

Identifier Source: org_study_id