Epidemiology of Infection in Acute Myeloid Leukemia (AML)

NCT06797648 | Not Yet Recruiting

• 1 other identifier: 7283
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

data analysis OTHER

follow up after 15 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Hematological diseases, other than AML
• Patients with an AML diagnosis prior to March 2025 but who relapsed during the period under examination

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli Irccs, Uoc Ematologia

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Study Officials

• LIVIO PAGANO, PROF

  FONDAZIONE POLICLINICO GEMELLI, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LIVIO PAGANO

CONTACT

+390630155530; LIVIO.PAGANO@POLICLINICOGEMELLI.IT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 28, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

IT (1)