Acute Myeloid Leukemia Clinical Trial
— LAM-SEPSISOfficial 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)
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
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 |
Country | Name | City | State |
---|---|---|---|
Italy | AOU Città della Salute e della Scienza di Torino | Torino |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Città della Salute e della Scienza di Torino |
Italy,
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 |
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