Acute Myeloid LeukemiaLAM-SEPSISNCT05249894
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
An observational study of Acute Myeloid Leukemia, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 23 Mar 2022to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Diagnosis of Acute Promyelocytic Leukemia (M3 AML)
- Age < 18 or >70 years
- Patient had not received intensive chemotherapy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOU Città della Salute e della Scienza di Torino
Torino, 10126
Chiara Frairia, MD
About this study
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)
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
- 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
- Medical subject headings
- Leukemia, Myeloid, Acute, Chemotherapy-Induced Febrile Neutropenia
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
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)
Measured: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
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)
Measured: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
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)
Measured: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
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)
Measured: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
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)
Measured: From date of fever onset until the date of fever resolution, assessed up to 60 days
Number of infections
Cumulative incidence of infections in patients with levofloxacin prophylaxis vs. patients without levofloxacin prophylaxis
Measured: From date of neutrophils count <500/mmc until the day of neutrophils count >=500/mmc, assessed up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start23 Mar 2022
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Frairia, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249894
- Sponsor's protocol ID
- LAM-SEPSIS
- Acronym
- LAM-SEPSIS
- Status last verified
- Mar 2022
- First submitted
- 20 Jan 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05249894
- Acronym / sponsor ID
- LAM-SEPSIS / LAM-SEPSIS
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosis of Acute Promyelocytic Leukemia (M3 AML)
- Age < 18 or >70 years
- Patient had not received intensive chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality risk
Time frame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
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)
7 secondary outcomes
Systemic Inflammatory Response Syndrome (SIRS) development
Time frame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
Amine requirement
Time frame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
Respiratory failure
Time frame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
Ventilation support
Time frame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
Intensive care unit (ICU) admission
Time frame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline
Bloodstream infections
Time frame: From date of fever onset until the date of fever resolution, assessed up to 60 days
Number of infections
Time frame: From date of neutrophils count <500/mmc until the day of neutrophils count >=500/mmc, assessed up to 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiara Frairia, MD (+390116335612, cfrairia@cittadellasalute.to.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality risk (time frame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.