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

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT05249894
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-02-22
• Status Verified: 2022-03
• Study Start: 2022-03-23
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-03-28
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
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)
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)
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

Trial Locations

Locations (1)

AOU Città della Salute e della Scienza di Torino; 🇮🇹 Torino, Italy