Incidenza di complicanze INfettive durante chemioterapia di induzione in pazienti affetti da Leucemia Acuta Mieloide profilassati e non con FLUorchinoloni: studio ossErvazioNale retrospettivo multiCEntrico di Real life (Studio INFLUENCER)

Principal Investigator: Monica Bocchia

Objectives of the study: 

Primary

Incidence of microbiologically documented bacterial infectious complications and related mortality during induction in the group with fluoroquinolone (FQ) prophylaxis and in the group without FQ prophylaxis in acute myeloid leukemia (AML) patients.

Secondary

To assess:

• Incidence of fever
• Incidence of fever of undetermined origin
• Bacterial and multi-drug resistance epidemiology
• Overall survival (40 days)
• Median hospitalization
• Response to induction chemotherapy

Study design:

Observational, retrospective, multicenter, non commercial (non profit) clinical study.

Retrospective data collection of consecutive AML patients who received high dose induction chemotherapy with or without Fluoroquinolone prophylaxis according to daily clinical practice, between 2018 and 2023.

Starting data: 20.05.2024

Population:

Inclusion Criteria:

• AML patients (NO Acute Promyelocitic Leukemia) eligible for high dose induction chemotherapy.
• Patients treated with high-dose induction chemotherapy with 3+7 regimen (+/- FLT3 inhibitors), fludarabine-based regimens, CPX-351 with or without FQ prophylaxis
• Age ≥ 18 years
• Signed informed consent, only requested for alive follow-up patients