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Clinical Trials/NCT07060612
NCT07060612
Active, not recruiting
Not Applicable

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

Instituto de Investigacion Sanitaria La Fe1 site in 1 country300 target enrollmentStarted: January 1, 2015Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Instituto de Investigacion Sanitaria La Fe
Enrollment
300
Locations
1
Primary Endpoint
Primary objectives

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Outcomes

Primary Outcomes

Primary objectives

Time Frame: 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Instituto de Investigacion Sanitaria La Fe
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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