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

Acute Myeloid Leukemia Clinical Trial

— LAM-SEPSIS  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05249894
• Other study ID #: LAM-SEPSIS
• Status: Recruiting
• Start date: March 23, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: March 2022
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Chiara Frairia, MD
• Phone: +390116335612
• Email: cfrairia[@]cittadellasalute.to.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Sepsis

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza di Torino	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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