Monocyte Distribution Width (MDW) in Hospital Practice

NCT04300530 | Unknown

• 1 other identifier: 2019.0376
• Study Type: observational
• Target: 3,098
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Sepsis; Infection

Keywords

Monocyte Distribution Width; Sepsis; Infection; Cross-sectional Study

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  1 day At antibiotic discontinuation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Adults (aged ≥18 years).
• Patients who had at least one FBC requested between 01 January 2020 and 31 December 2020

You may not qualify if:

• Children and adolescents (\< 18 years).
• Patients without a FBC.

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (2)

St. George's University Hospitals Foundation Trust

London, SW17 0RE, United Kingdom

Location

St. Georges Hospital Foundation Trust

London, SW17 0RE, United Kingdom

Location

MeSH Terms

Conditions

Sepsis; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 9, 2020
• Study Start: July 15, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

GB (2)