Gram Type Infection-Specific Sepsis Identification Using Machine Learning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Subpopulation-Specific Sepsis Identification Using Machine Learning

NCT03644940

Sepsis Severe Sepsis Septic Shock

WITHDRAWN PHASE2

RCT of Sepsis Machine Learning Algorithm

NCT03882476

Sepsis Severe Sepsis Septic Shock

WITHDRAWN PHASE2

Unsupervised Machine Learning for Clustering of Septic Patients to Determine Optimal Treatment

NCT03752489

Sepsis Severe Sepsis Septic Shock

UNKNOWN PHASE2

Effect of a Sepsis Prediction Algorithm on Clinical Outcomes

NCT03960203

Severe Sepsis

COMPLETED NA

An Algorithm Driven Sepsis Prediction Biomarker

NCT03015454

Sepsis Septic Shock Severe Sepsis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis Severe Sepsis Septic Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gram type infection-specific algorithm

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

Group Type EXPERIMENTAL

InSight

Intervention Type DIAGNOSTIC_TEST

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.

Standard treatment protocol

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

InSight

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.