Evaluation of Infective Risk, Efficacy of Bacterial Prophylaxis and Validation of Sepsis Scores NEWS (National Early Warning Score) and qSOFA (Quick Sequential Organ Failure Assessment) in Patient With Acute Myeloid Leukemia Treated With Intensive Chemotherapy

Study Overview
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Brief Summary
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Evaluation of Infective Risk, Efficacy of Bacterial Prophylaxis and Validation of sepsis scores NEWS (National Early Warning Score) and qSOFA (Quick Sequential Organ Failure Assessment) in Patient With Acute Myeloid Leukemia Treated With Intensive Chemotherapy

Official Title
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Evaluation of Infective Risk, Efficacy of Bacterial Prophylaxis and Validation of Sepsis Scores NEWS (National Early Warning Score) and qSOFA (Quick Sequential Organ Failure Assessment) in Patient With Acute Myeloid Leukemia Treated With Intensive Chemotherapy (LAM-SEPSIS)

Conditions
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Acute Myeloid Leukemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of non M3 Acute Myeloid Leukemia according to WHO (World Health Organization) 2008 criteria Age >= 18 years and <= 70 years Patient had received intensive chemotherapy either as induction or consolidation regimen Period of observation: January 2001 - December 2019 Written informed consent Exclusion Criteria: Diagnosis of Acute Promyelocytic Leukemia (M3 AML) Age < 18 or >70 years Patient had not received intensive chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality risk | Ability of NEWS and qSOFA score to predict mortality risk calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve) | At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic Inflammatory Response Syndrome (SIRS) development | Ability of NEWS and qSOFA score to predict SIRS development calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve) | At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline | 
| Amine requirement | Ability of NEWS and qSOFA score to predict vasoactive drugs requirement calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve) | At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline | 
| Respiratory failure | Ability of NEWS and qSOFA score to predict respiratory failure calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve) | At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline | 
| Ventilation support | Ability of NEWS and qSOFA score to predict ventilation support necessity calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve) | At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline | 
| Intensive care unit (ICU) admission | Ability of NEWS and qSOFA score to predict ICU admission calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve) | At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline | 
| Bloodstream infections | Ability of NEWS and qSOFA score to predict severity of bloodstream infection calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve) | From date of fever onset until the date of fever resolution, assessed up to 60 days | 
| Number of infections | Cumulative incidence of infections in patients with levofloxacin prophylaxis vs. patients without levofloxacin prophylaxis | From date of neutrophils count <500/mmc until the day of neutrophils count >=500/mmc, assessed up to 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia, Sepsis score, National Early Warning Score (NEWS), quick Sequential Organ Failure Assessment (qSOFA), chemotherapy-induced febrile neutropenia, Antibiotics prophylaxis