Clinical trial NCT05249894: 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
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: Mortality risk
timeFrame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
Secondary outcomes:
measure: Systemic Inflammatory Response Syndrome (SIRS) development
timeFrame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
measure: Amine requirement
timeFrame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
measure: Respiratory failure
timeFrame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
measure: Ventilation support
timeFrame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
measure: Intensive care unit (ICU) admission
timeFrame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
measure: Bloodstream infections
timeFrame: From date of fever onset until the date of fever resolution, assessed up to 60 days
measure: Number of infections
timeFrame: From date of neutrophils count <500/mmc until the day of neutrophils count >=500/mmc, assessed up to 60 days
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino
Study officials:
References: