Incidence and Risk Factors for the Development of Invasive Fungal Infection in Patients Diagnosed With Acute Myeloblastic Leukemia (HIFA)

NCT07060612 | Active Not Recruiting

• 1 other identifier: 2025-0322-1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Patients diagnosed with acute myeloblastic leukemia (AML) who receive intensive chemotherapy treatment have a high incidence of invasive fungal infection (IFI). IFI is a significant cause of morbidity and mortality in this population. Its diagnosis is generally challenging, leading to delays in treatment initiation and a worse prognosis. Various strategies have been proposed to improve outcomes: prophylaxis, empirical treatment, and preemptive strategies, but the optimal approach remains unknown. Several authors advocate for tailoring IFI control strategies based on local IFI incidence and the risk factors present in each epidemiological area. In AML patients treated at our center, a thorough understanding of IFI incidence, associated risk factors, and the strategies adopted for its control during different historical periods will allow us to optimize patient management in the future to improve outcomes. To this end, the investigators propose conducting a retrospective epidemiological study that captures routine clinical practice in the management of IFI at our center from January 1, 2015, to December 31, 2024. This study will record data on diagnosis, patient characteristics, and the development of IFI, regardless of age or treatment received. Secondarily, the investigators aim to determine the incidence and epidemiological characteristics of IFI in this population, identify and confirm risk factors, and retrospectively evaluate the diagnostic and control strategies adopted for IFI across different historical periods. The study design will be retrospective, documenting routine IFI management practices at our center. No diagnostic or therapeutic interventions will be performed. All patients diagnosed with AML from January 1, 2015, to December 31, 2024, will be included, regardless of AML subtype, disease progression, or treatment received. Data will be collected on key AML characteristics at diagnosis, treatment received and number of cycles, IFI diagnosis according to the 2008 EORTC/MSG criteria, and the management of this complication.

Conditions

AML

Keywords

Fungal; AML

Outcome Measures

Primary Outcomes (1)

• Primary objectives

  To evaluate the incidence and risk factors for the development of IFI/BIFD in patients diagnosed with AML, regardless of the treatment received (first-line and relapsed/refractory patients).

  9 years

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive unselected patients with AML diagnosed at the Hospital Universitario y Politécnico La Fe between 2015 and 2024. Clinical records of all patients will be reviewed to assess their eligibility for this retrospective study

You may qualify if:

• Patients diagnosed with AML regardless of the treatment received (first line and relapsed/refractory).
• Patients older than 15 years (adult unit) No contraindications for antifungal therapy/prophylaxis.

You may not qualify if:

• Patients with acute promyelocytic leukemia (APL). Patients with insufficient data (not evaluable).

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, 46026, Spain

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: July 11, 2025
• Study Start: January 1, 2015
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-06

Locations

ES (1)