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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

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05249894
Acronym
LAM-SEPSIS
Enrollment
400
Registered
2022-02-22
Start date
2022-03-23
Completion date
2022-09-01
Last updated
2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia, Sepsis score, National Early Warning Score (NEWS), quick Sequential Organ Failure Assessment (qSOFA), chemotherapy-induced febrile neutropenia, Antibiotics prophylaxis

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

Interventions

None listed

Sponsors

A.O.U. Città della Salute e della Scienza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality riskAt baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baselineAbility 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

MeasureTime frameDescription
Amine requirementAt baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baselineAbility 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 failureAt baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baselineAbility 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 supportAt baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baselineAbility 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)
Systemic Inflammatory Response Syndrome (SIRS) developmentAt baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baselineAbility 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)
Bloodstream infectionsFrom date of fever onset until the date of fever resolution, assessed up to 60 daysAbility 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 infectionsFrom date of neutrophils count <500/mmc until the day of neutrophils count >=500/mmc, assessed up to 60 daysCumulative incidence of infections in patients with levofloxacin prophylaxis vs. patients without levofloxacin prophylaxis
Intensive care unit (ICU) admissionAt baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baselineAbility 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)

Countries

Italy

Contacts

Primary ContactChiara Frairia, MD
cfrairia@cittadellasalute.to.it+390116335612

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026