A Clinical Trial to Evaluate the Efficacy of the Morley Medical Sepsis (MMS) Software Device in Predicting Sepsis in Adult Patients Using Artificial Intelligence (AI) Machine Learning Algorithms

A Non-Randomized Clinical Trial to Investigate the Efficacy of the Morley Medical Sepsis (MMS) Software Device in the Prediction and Early Detection of Sepsis

This is a pivotal medical device clinical trial evaluating the clinical outcomes in hospitalized patients monitored with the Morley Medical Sepsis Software Device. The device uses unique AI machine learning algorithms to analyze patient data in real time and generate clinical decision support sepsis risk predictions for clinicians.

Study Overview

• Status: Unknown
• Conditions: Sepsis
• Intervention / Treatment: Device: Morley Medical Sepsis Software Device

• Study Type: Interventional
• Enrollment (Anticipated): 10000
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patient 18 years of age or older
• Patient is admitted or had been admitted to a participating healthcare facility

Exclusion Criteria:

• Sepsis diagnosis present on admission
• Involvement in a clinical trial of another investigational product with similar purpose

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Arm; The patients enrolled into the investigational arm at each participating hospital will be monitored with the Morley Medical Sepsis (MMS) Software Device for the prediction and early identification of sepsis.	Device: Morley Medical Sepsis Software Device; The Morley Medical Sepsis (MMS) Software Device is a predictive analytics, stand-alone, cloud-based software system with no hardware components. The software acquires patient data from the electronic medical record, processes the data using unique artificial intelligence (AI) powered algorithms, and generates clinical decision support outputs that aid in the proactive delivery of customized and efficient care for patients. The software output is made available to the end users (trained medical professionals) via an intuitive user interface displayed on desktop computers or mobile communication devices such as laptops, smartphones or tablets.
No Intervention: Control Arm; The patients enrolled into the control group of each participating hospital will not be monitored with the Morley Medical Sepsis (MMS) Software Device for the prediction and early identification of sepsis. These patients will be monitored according to each institution's standard sepsis screening practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-hospital sepsis prevalence	Up to 8 weeks
In-hospital sepsis related 30-day mortality	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
In-hospital all-cause 30-day mortality	30 days
Hospital length of stay	Up to 8 weeks
Hospital re-admission	Up to 8 weeks
Time of initial IV fluids administration	Day 1 to Day 30, or until discharge
Time of initial vasopressors administration	Day 1 to Day 30, or until discharge
Time of initial antibiotics administration	Day 1 to Day 30, or until discharge
Time of initial blood microbiology culture	Day 1 to Day 30, or until discharge
Sepsis related adverse outcomes (septic shock)	Day 1 to Day 30, or until discharge
Sepsis prediction to onset time	Day 1 to Day 30, or until discharge
Sensitivity and specificity of sepsis prediction	Day 1 to Day 30, or until discharge

Collaborators and Investigators

• Sponsor: Morley Medical
• Collaborators: Morley Research Consortium

Study record dates

Study Major Dates

• Study Start (Anticipated): October 31, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: MMSEP1901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes