SepsisNCT04300530
Monocyte Distribution Width (MDW) in Hospital Practice
An observational study of Sepsis and Infection, run by St George's, University of London at 2 sites in United Kingdom.
Trial summary
Infections are an important cause of mortality and morbidity worldwide. Infections vary greatly in severity and can be caused by viruses, bacteria, fungi or protozoa. The rapid assessment of a patient to determine whether they have an infection and whether to treat with antibiotics is essential. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 3,098 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 Jul 2020to 31 Dec 2021
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Coprimary objective 1: Admitted in ED for suspected sepsis between 01 January 2020 and 31 December 2020. Coprimary objective 2: Admitted to SGHFT wards for any reason between 01 January 2020 and 31 December 2020.
Who may be able to join
- Adults (aged ≥18 years).
- Patients who had at least one FBC requested between 01 January 2020 and 31 December 2020
Who cannot join
- Children and adolescents (< 18 years).
- Patients without a FBC.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
St. George's University Hospitals Foundation Trust
London, SW17 0RE
St. Georges Hospital Foundation Trust
London, SW17 0RE
About this study
Official title: The Use of a Novel Monocyte Distribution Width (MDW) Biomarker of Infection in Hospital Practice
Infections are an important cause of mortality and morbidity worldwide. Infections vary greatly in severity and can be caused by viruses, bacteria, fungi or protozoa. The rapid assessment of a patient to determine whether they have an infection and whether to treat with antibiotics is essential.
Monocyte Distribution Width (MDW) is a (CE marked) new biomarker that has recently been studied in the emergency department (ED). This novel biomarker, which is currently available as a part of the panel of results from full blood count, holds the promise of reducing unnecessary antibiotic use and improving the outcome of patient's infections.
Read more
Sepsis (blood poisoning) is a life-threatening condition that affects millions of people worldwide. The chance of dying from sepsis increases if there is a delay in treatment with the right antibiotics, but also using antibiotics incorrectly might lead to antibiotic resistance, which is dangerous for patients in the long term, as treatments might no longer work for them.
An antibiotic is a substance produced naturally by microorganisms or synthetically by chemists in a laboratory. Antibiotics are capable of inhibiting the growth of or killing bacteria but are not effective against the viruses that cause many illnesses. The inappropriate use of antibiotics for these types of non-bacterial infections as well as the more frequent use of broad-spectrum antibiotics has caused the emergence of newer strains of bacteria that are resistant to many antibiotics.
Rapid diagnostics are essential to accurately identify cases of sepsis that require antibiotic therapy; particularly since clinical criteria alone is often insufficient to avoid misclassifying patients with sepsis who require antibiotics. However, the high costs of current laboratory markers, along with the variable level of evidence supporting their use in sepsis and respiratory infections means that these are not in routine use.
This study proposes to make use of data collected routinely at St. George's University Hospital to evaluate the accuracy of MDW as a marker for sepsis in adult patients admitted to the ED, as well as to explore its usefulness in supporting clinical decisions related to the discontinuation of antibiotic treatment in hospitalised adult patients. This observational study will not involve changes in patient management as all the data would be analysed retrospectively.
Read the detailed description
This is an observational, cross-sectional (single-gate) study comparing the results of the index test (MDW) against different reference standards (operational definitions). One of these references identifies a situation when IV antibiotics need to start (i.e. sepsis diagnosis) and the other, a situation when they need to be discontinued (i.e. clinical improvement).
One reference standard will be Sepsis 3 definition and will be operationalised in ED using qSOFA ≥ 2. This is used in ED as a bedside score to identify patients with suspected sepsis.
As part of the exploratory objectives for this ED dataset, sepsis will be operationalised using other common scores (SOFA, NEWS2, REDS, and Simplified-MISSED scores), and also against the reference standard for confirming septicaemia (blood culture results).
The second reference standard will be expert clinical criteria. Antimicrobial stewardship groups and care team review antibiotic treatments for all inpatients at regular intervals. Decisions on whether discontinuation (due to clinical improvement) is indicated is ultimately based on clinical criteria.
As part of the exploratory objectives for the dataset of in-patients, sepsis will be operationalised using the results of blood cultures. Also, different subpopulations will be described on the basis of MDW levels:
- Hospitalised patients admitted through ED but not in the sepsis pathway.
- Hospital Acquired Infections (HAI), surgical operations, and IV antibiotic treatment modification due to lack of clinical improvement and/or antibiotic resistance.
- Non-bacterial causes of septic syndrome (i.e. surgical tissue injury, myocardial infraction, pancreatitis, pulmonary-thromboembolism, influenza, RSV, autoimmune and neoplastic processes).
- Keywords
- Monocyte Distribution Width, Sepsis, Infection, Cross-sectional Study
- Medical subject headings
- Sepsis, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of MDW to identify sepsis in adults presenting to the ED.
Sensitivity and Specificity of MDW to identify sepsis in adults presenting to the ED against the reference clinical score, i.e. Sepsis 3 definition (operationalization of this definition in the ED is through qSOFA score).
Measured: 1 day At ED admission
Sensitivity and Specificity of MDW to predict clinical decisions related to IV antibiotic discontinuation in hospitalised adult patients.
Sensitivity and Specificity of MDW to predict clinical decisions related to IV antibiotic discontinuation in hospitalised adult patients, against the current reference (clinical criteria). This will be measured when antibiotic treatment is assessed for discontinuation by direct care clinicians and stewardship team (the last full blood count at time of assessment will be used to obtain MDW values).
Measured: 1 day At antibiotic discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start15 Jul 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2021 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,098 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300530
- Sponsor's protocol ID
- 2019.0376
- Status last verified
- Jan 2021
- First submitted
- 3 Mar 2020
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Novel Monocyte Distribution Width (MDW) Biomarker of Infection in Hospital Practice
- ClinicalTrials.gov ID
- NCT04300530
- Acronym / sponsor ID
- 2019.0376
- Keywords
- Monocyte Distribution Width, Sepsis, Infection, Cross-sectional Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,098 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Mar 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.
Infections are an important cause of mortality and morbidity worldwide. Infections vary greatly in severity and can be caused by viruses, bacteria, fungi or protozoa. The rapid assessment of a patient to determine whether they have an infection and whether to treat with antibiotics is essential.
Monocyte Distribution Width (MDW) is a (CE marked) new biomarker that has recently been studied in the emergency department (ED). This novel biomarker, which is currently available as a part of the panel of results from full blood count, holds the promise of reducing unnecessary antibiotic use and improving the outcome of patient's infections.
Sepsis (blood poisoning) is a life-threatening condition that affects millions of people worldwide. The chance of dying from sepsis increases if there is a delay in treatment with the right antibiotics, but also using antibiotics incorrectly might lead to antibiotic resistance, which is dangerous for patients in the long term, as treatments might no longer work for them.
An antibiotic is a substance produced naturally by microorganisms or synthetically by chemists in a laboratory. Antibiotics are capable of inhibiting the growth of or killing bacteria but are not effective against the viruses that cause many illnesses. The inappropriate use of antibiotics for these types of non-bacterial infections as well as the more frequent use of broad-spectrum antibiotics has caused the emergence of newer strains of bacteria that are resistant to many antibiotics.
Rapid diagnostics are essential to accurately identify cases of sepsis that require antibiotic therapy; particularly since clinical criteria alone is often insufficient to avoid misclassifying patients with sepsis who require antibiotics. However, the high costs of current laboratory markers, along with the variable level of evidence supporting their use in sepsis and respiratory infections means that these are not in routine use.
This study proposes to make use of data collected routinely at St. George's University Hospital to evaluate the accuracy of MDW as a marker for sepsis in adult patients admitted to the ED, as well as to explore its usefulness in supporting clinical decisions related to the discontinuation of antibiotic treatment in hospitalised adult patients. This observational study will not involve changes in patient management as all the data would be analysed retrospectively.
Detailed description
This is an observational, cross-sectional (single-gate) study comparing the results of the index test (MDW) against different reference standards (operational definitions). One of these references identifies a situation when IV antibiotics need to start (i.e. sepsis diagnosis) and the other, a situation when they need to be discontinued (i.e. clinical improvement).
One reference standard will be Sepsis 3 definition and will be operationalised in ED using qSOFA ≥ 2. This is used in ED as a bedside score to identify patients with suspected sepsis.
As part of the exploratory objectives for this ED dataset, sepsis will be operationalised using other common scores (SOFA, NEWS2, REDS, and Simplified-MISSED scores), and also against the reference standard for confirming septicaemia (blood culture results).
The second reference standard will be expert clinical criteria. Antimicrobial stewardship groups and care team review antibiotic treatments for all inpatients at regular intervals. Decisions on whether discontinuation (due to clinical improvement) is indicated is ultimately based on clinical criteria.
As part of the exploratory objectives for the dataset of in-patients, sepsis will be operationalised using the results of blood cultures. Also, different subpopulations will be described on the basis of MDW levels:
- Hospitalised patients admitted through ED but not in the sepsis pathway.
- Hospital Acquired Infections (HAI), surgical operations, and IV antibiotic treatment modification due to lack of clinical improvement and/or antibiotic resistance.
- Non-bacterial causes of septic syndrome (i.e. surgical tissue injury, myocardial infraction, pancreatitis, pulmonary-thromboembolism, influenza, RSV, autoimmune and neoplastic processes).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Coprimary objective 1: Admitted in ED for suspected sepsis between 01 January 2020 and 31 December 2020. Coprimary objective 2: Admitted to SGHFT wards for any reason between 01 January 2020 and 31 December 2020.
Key inclusion criteria (2 listed)
- Adults (aged ≥18 years).
- Patients who had at least one FBC requested between 01 January 2020 and 31 December 2020
Key exclusion criteria (2 listed)
- Children and adolescents (< 18 years).
- Patients without a FBC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and Specificity of MDW to identify sepsis in adults presenting to the ED.
Time frame: 1 day At ED admission
Sensitivity and Specificity of MDW to identify sepsis in adults presenting to the ED against the reference clinical score, i.e. Sepsis 3 definition (operationalization of this definition in the ED is through qSOFA score).
Sensitivity and Specificity of MDW to predict clinical decisions related to IV antibiotic discontinuation in hospitalised adult patients.
Time frame: 1 day At antibiotic discontinuation
Sensitivity and Specificity of MDW to predict clinical decisions related to IV antibiotic discontinuation in hospitalised adult patients, against the current reference (clinical criteria). This will be measured when antibiotic treatment is assessed for discontinuation by direct care clinicians and stewardship team (the last full blood count at time of assessment will be used to obtain MDW values).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Infection, run by St George's, University of London at 2 sites in United Kingdom.
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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of MDW to identify sepsis in adults presenting to the ED. (time frame: 1 day At ED admission). 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 2 Feb 2021.