Gram Type Infection-Specific Sepsis Identification Using Machine Learning

Phase 2

Withdrawn

• Conditions: Sepsis; Severe Sepsis; Septic Shock
• Interventions: Diagnostic Test: InSight

• Registration Number: NCT03734484
• Lead Sponsor: Dascena

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-17
• Last Update Posted: 2021-09-23
• Study Start: 2022-05-01
• Primary Completion: 2022-11-30
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gram type infection-specific algorithm	InSight	The experimental arm will involve patients monitored by the Gram type infection-customized version of InSight.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in administration of unnecessary antibiotics	Through study completion, an average of 8 months	Changes in total hours spent on antibiotics