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)

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)

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

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Chiara Frairia, MD; Phone Number: +390116335612; Email: cfrairia@cittadellasalute.to.it

Study Locations

• Italy
  • Torino, Italy, 10126
    • Recruiting
    • AOU Città della Salute e della Scienza di Torino
    • Contact: Chiara Frairia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients affected by Acute Myeloid Leukemia that had received between JAN2001 and DEC2019 an intensive chemotherapy cycle either as induction or consolidation regimen

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Acute Myeloid Leukemia; Antibiotics prophylaxis; Sepsis score; National Early Warning Score (NEWS); quick Sequential Organ Failure Assessment (qSOFA); chemotherapy-induced febrile neutropenia
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Neoplasms by Histologic Type; Neoplasms; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: LAM-SEPSIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No