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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Device: Morley Medical Sepsis Software Device


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a pivotal medical device clinical trial comparing the clinical outcomes in hospitalized patients monitored with the MMS Software Device for the prediction and early detection of sepsis versus patients monitored with current standard sepsis scoring systems at participating clinical trial sites. This will be conducted through a non-randomized multi-center, non-blinded, clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Arm<br>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<br>* 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.<br>|
| No Intervention: Control Arm<br>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 | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital sepsis prevalence |  | Up to 8 weeks | 
| In-hospital sepsis related 30-day mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |