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

Incidencia y Factores de Riesgo Para el Desarrollo de infección fúngica Invasiva en Pacientes Con diagnóstico de Leucemia mieloblástica Aguda

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07060612

Acronym

HIFA

Enrollment

300

Registered

2025-07-11

Start date

2015-01-01

Completion date

2026-10-31

Last updated

2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML

Keywords

Fungal, AML

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Primary objectives	9 years	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).

Countries

Spain

Outcome results