LAM-SEPSIS: 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

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino (Other)

Overall Status

Recruiting

CT.gov ID

NCT05249894

Collaborator

(none)

400

Enrollment

Location

5.3

Anticipated Duration (Months)

75.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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)

Actual Study Start Date :

Mar 23, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Outcome Measures

Primary Outcome Measures

Mortality risk [At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline]
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)

Secondary Outcome Measures

Systemic Inflammatory Response Syndrome (SIRS) development [At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline]
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)
Amine requirement [At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline]
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)
Respiratory failure [At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline]
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)
Ventilation support [At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline]
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)
Intensive care unit (ICU) admission [At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline]
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)
Bloodstream infections [From date of fever onset until the date of fever resolution, assessed up to 60 days]
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)
Number of infections [From date of neutrophils count <500/mmc until the day of neutrophils count >=500/mmc, assessed up to 60 days]
Cumulative incidence of infections in patients with levofloxacin prophylaxis vs. patients without levofloxacin prophylaxis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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