Hospital Universitario y Politécnico La Fe
Valencia, 46026, Spain
NCT Number: NCT07060612
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.
This study is active but is not currently recruiting participants.
Notify Me15 year and older
All sexes
Observational
Valencia, 46026, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients older than 15 years (adult unit) No contraindications for antifungal therapy/prophylaxis.
Exclusion criteria
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).
Instituto de Investigacion Sanitaria La Fe
Other
Incidencia y Factores de Riesgo Para el Desarrollo de infección fúngica Invasiva en Pacientes Con diagnóstico de Leucemia mieloblástica Aguda
Acronym: HIFA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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