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Withdrawn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
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
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
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Withdrawn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
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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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