Gram Type Infection-Specific Sepsis Identification Using Machine Learning

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03734484

Enrollment

Registered

2018-11-08

Start date

2022-05-01

Completion date

2023-03-01

Last updated

2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock, Severe Sepsis

Keywords

Dascena, Gram infection, antibiotic administration, machine learning, algorithm, diagnostic

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.

Interventions

DIAGNOSTIC_TESTInSight

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in time to antibiotic administration	Through study completion, an average of 8 months	Change in time period between diagnosis of Gram infection and administration of antibiotics to treat infection

Secondary

Measure	Time frame	Description
Change in administration of unnecessary antibiotics	Through study completion, an average of 8 months	Changes in amount of secondary antibiotics administered

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026