NCT05249894

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

March 23, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

January 20, 2022

Last Update Submit

March 25, 2022

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid LeukemiaSepsis scoreNational Early Warning Score (NEWS)quick Sequential Organ Failure Assessment (qSOFA)chemotherapy-induced febrile neutropeniaAntibiotics prophylaxis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Systemic Inflammatory Response Syndrome (SIRS) development

    At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline

  • Amine requirement

    At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline

  • Respiratory failure

    At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline

  • Ventilation support

    At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline

  • Intensive care unit (ICU) admission

    At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis of Acute Promyelocytic Leukemia (M3 AML)
  • Age \< 18 or \>70 years
  • Patient had not received intensive chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Città della Salute e della Scienza di Torino

Torino, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteChemotherapy-Induced Febrile Neutropenia

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesFebrile NeutropeniaNeutropeniaAgranulocytosisLeukopeniaCytopeniaLeukocyte Disorders

Central Study Contacts

Chiara Frairia, MD

CONTACT

+390116335612cfrairia@cittadellasalute.to.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor in Hematology

Study Record Dates

First Submitted

January 20, 2022

First Posted

February 22, 2022

Study Start

March 23, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

March 28, 2022

Record last verified: 2022-03

Locations

IT(1)