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Gram Type Infection-Specific Sepsis Identification Using Machine Learning

Primary Purpose

Sepsis, Severe Sepsis, Septic Shock

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
InSight
Sponsored by
Dascena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sepsis focused on measuring Dascena, Gram infection, antibiotic administration, machine learning, algorithm, diagnostic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All adults above age 18 who are a member of one of the three subpopulations studied in this trial (patients with Gram-positive infection, patients with Gram-negative infection, and patients with mixed Gram-positive and Gram-negative infection) are eligible to participate in the study.

Exclusion Criteria:

  • Under age 18
  • No record of Gram infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Gram type infection-specific algorithm

    Standard treatment protocol

    Arm Description

    The experimental arm will involve patients monitored by the Gram type infection-customized version of InSight.

    The control arm will involve patients treated with the regular diagnosis and treatment protocol for gram-type infection, where fluid cultures are run to determine infection type.

    Outcomes

    Primary Outcome Measures

    Change in time to antibiotic administration
    Change in time period between diagnosis of Gram infection and administration of antibiotics to treat infection

    Secondary Outcome Measures

    Change in administration of unnecessary antibiotics
    Changes in amount of secondary antibiotics administered
    Change in administration of unnecessary antibiotics
    Changes in total hours spent on antibiotics

    Full Information

    First Posted
    November 1, 2018
    Last Updated
    September 17, 2021
    Sponsor
    Dascena
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03734484
    Brief Title
    Gram Type Infection-Specific Sepsis Identification Using Machine Learning
    Official Title
    Gram Type Infection-Specific Sepsis Identification Using Machine Learning
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    study was not started.
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    November 30, 2022 (Anticipated)
    Study Completion Date
    March 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dascena

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The focus of this study will be to conduct a prospective, randomized controlled trial (RCT) at Cape Regional Medical Center (CRMC), Oroville Hospital (OH), and UCSF Medical Center (UCSF) in which a Gram type infection-specific algorithm will be applied to EHR data for the detection of severe sepsis. For patients determined to have a high risk of severe sepsis, the algorithm will generate automated voice, telephone notification to nursing staff at CRMC, OH, and UCSF. The algorithm's performance will be measured by analysis of the primary endpoint, time to antibiotic administration. The secondary endpoint will be reduction in the administration of unnecessary antibiotics, which includes reductions in secondary antibiotics and reductions in total time on antibiotics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sepsis, Severe Sepsis, Septic Shock
    Keywords
    Dascena, Gram infection, antibiotic administration, machine learning, algorithm, diagnostic

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gram type infection-specific algorithm
    Arm Type
    Experimental
    Arm Description
    The experimental arm will involve patients monitored by the Gram type infection-customized version of InSight.
    Arm Title
    Standard treatment protocol
    Arm Type
    No Intervention
    Arm Description
    The control arm will involve patients treated with the regular diagnosis and treatment protocol for gram-type infection, where fluid cultures are run to determine infection type.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    InSight
    Intervention Description
    The InSight algorithm which draws information from a patient's electronic health record (EHR) to predict the onset of severe sepsis, and in this study will be customized to differentiate between various Gram-type infections.
    Primary Outcome Measure Information:
    Title
    Change in time to antibiotic administration
    Description
    Change in time period between diagnosis of Gram infection and administration of antibiotics to treat infection
    Time Frame
    Through study completion, an average of 8 months
    Secondary Outcome Measure Information:
    Title
    Change in administration of unnecessary antibiotics
    Description
    Changes in amount of secondary antibiotics administered
    Time Frame
    Through study completion, an average of 8 months
    Title
    Change in administration of unnecessary antibiotics
    Description
    Changes in total hours spent on antibiotics
    Time Frame
    Through study completion, an average of 8 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All adults above age 18 who are a member of one of the three subpopulations studied in this trial (patients with Gram-positive infection, patients with Gram-negative infection, and patients with mixed Gram-positive and Gram-negative infection) are eligible to participate in the study. Exclusion Criteria: Under age 18 No record of Gram infection
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ritankar Das, MSc
    Organizational Affiliation
    Dascena
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27699003
    Citation
    Calvert J, Mao Q, Hoffman JL, Jay M, Desautels T, Mohamadlou H, Chettipally U, Das R. Using electronic health record collected clinical variables to predict medical intensive care unit mortality. Ann Med Surg (Lond). 2016 Sep 6;11:52-57. doi: 10.1016/j.amsu.2016.09.002. eCollection 2016 Nov.
    Results Reference
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    PubMed Identifier
    29435343
    Citation
    Shimabukuro DW, Barton CW, Feldman MD, Mataraso SJ, Das R. Effect of a machine learning-based severe sepsis prediction algorithm on patient survival and hospital length of stay: a randomised clinical trial. BMJ Open Respir Res. 2017 Nov 9;4(1):e000234. doi: 10.1136/bmjresp-2017-000234. eCollection 2017.
    Results Reference
    background
    PubMed Identifier
    29374661
    Citation
    Mao Q, Jay M, Hoffman JL, Calvert J, Barton C, Shimabukuro D, Shieh L, Chettipally U, Fletcher G, Kerem Y, Zhou Y, Das R. Multicentre validation of a sepsis prediction algorithm using only vital sign data in the emergency department, general ward and ICU. BMJ Open. 2018 Jan 26;8(1):e017833. doi: 10.1136/bmjopen-2017-017833.
    Results Reference
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    Gram Type Infection-Specific Sepsis Identification Using Machine Learning

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