SepsisNCT04606862
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 study testing Morley Medical Sepsis Software Device in people with Sepsis, run by Morley Medical.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- Morley Medical Sepsis Software Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patient 18 years of age or older
- Patient is admitted or had been admitted to a participating healthcare facility
Who cannot join
- Sepsis diagnosis present on admission
- Involvement in a clinical trial of another investigational product with similar purpose
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Sepsis
- Being tested
- Morley Medical Sepsis Software Device
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morley Medical Sepsis Software DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Arm | Experimental | 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. Receives: Device: Morley Medical Sepsis Software Device |
| Control Arm | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
In-hospital sepsis prevalence
Measured: Up to 8 weeks
In-hospital sepsis related 30-day mortality
Measured: 30 days
Secondary outcomes (10)
In-hospital all-cause 30-day mortality
Measured: 30 days
Hospital length of stay
Measured: Up to 8 weeks
Hospital re-admission
Measured: Up to 8 weeks
Time of initial IV fluids administration
Measured: Day 1 to Day 30, or until discharge
Time of initial vasopressors administration
Measured: Day 1 to Day 30, or until discharge
Time of initial antibiotics administration
Measured: Day 1 to Day 30, or until discharge
Time of initial blood microbiology culture
Measured: Day 1 to Day 30, or until discharge
Sepsis related adverse outcomes (septic shock)
Measured: Day 1 to Day 30, or until discharge
Sepsis prediction to onset time
Measured: Day 1 to Day 30, or until discharge
Sensitivity and specificity of sepsis prediction
Measured: Day 1 to Day 30, or until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start31 Oct 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morley Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Morley Research Consortium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606862
- Sponsor's protocol ID
- MMSEP1901
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04606862
- Acronym / sponsor ID
- MMSEP1901
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Morley MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Morley Research Consortium
- Study start
- 31 Oct 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Investigational Arm | Experimental | Device: Morley Medical Sepsis Software DeviceThe 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. |
| Control Arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female patient 18 years of age or older
- Patient is admitted or had been admitted to a participating healthcare facility
Key exclusion criteria (2 listed)
- Sepsis diagnosis present on admission
- Involvement in a clinical trial of another investigational product with similar purpose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morley Medical Sepsis Software DeviceThe 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. | Device | Investigational Arm |
Primary outcome
In-hospital sepsis prevalence
Time frame: Up to 8 weeks
In-hospital sepsis related 30-day mortality
Time frame: 30 days
10 secondary outcomes
In-hospital all-cause 30-day mortality
Time frame: 30 days
Hospital length of stay
Time frame: Up to 8 weeks
Hospital re-admission
Time frame: Up to 8 weeks
Time of initial IV fluids administration
Time frame: Day 1 to Day 30, or until discharge
Time of initial vasopressors administration
Time frame: Day 1 to Day 30, or until discharge
Time of initial antibiotics administration
Time frame: Day 1 to Day 30, or until discharge
Time of initial blood microbiology culture
Time frame: Day 1 to Day 30, or until discharge
Sepsis related adverse outcomes (septic shock)
Time frame: Day 1 to Day 30, or until discharge
Sepsis prediction to onset time
Time frame: Day 1 to Day 30, or until discharge
Sensitivity and specificity of sepsis prediction
Time frame: Day 1 to Day 30, or until discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Morley Medical Sepsis Software Device in people with Sepsis, run by Morley Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kiki Diorgu, MD, MBA (4048911750, adiorgu@morleymed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital sepsis prevalence (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.