NCT04300530

Monocyte Distribution Width (MDW) in Hospital Practice

Status unknown Last updated 2 February 2021

What this trial tests

trial in Sepsis in 3,098 participants. Status unknown.

Timeline

15 July 2020

Primary endpoint
31 December 2020

31 December 2021

Quick facts

Lead sponsor	St George's, University of London
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	3,098
Start date	15 July 2020
Primary completion	31 December 2020
Estimated completion	31 December 2021
Sites	2 locations across United Kingdom

Conditions studied

• Sepsis — all drugs for Sepsis →
• Infection — all drugs for Infection →

Sponsor

St George's, University of London

Who can join

18 and older, any sex, with Sepsis or Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Increased monocyte distribution width in COVID-19 and sepsis arises from a complex interplay of altered monocyte cellular size and subset frequency.
   Cusinato M, Hadcocks L, Yona S, Planche T, et al · · 2022 · cited 11× · PMID 35915915 · DOI 10.1111/ijlh.13941