Gram Type Infection-Specific Sepsis Identification Using Machine Learning

Dascena

Status and phase: Withdrawn; Phase 2

Conditions: Severe Sepsis; Septic Shock; Sepsis

Treatments: Diagnostic Test: InSight

Study type: Interventional

Funder types: Industry

Identifiers

NCT03734484

01072019

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Gram type infection-specific algorithm

Experimental group

Description:

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

Treatment:

Diagnostic Test: InSight

Standard treatment protocol

No Intervention group

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.