Monocyte Distribution Width (MDW) in the General Population of Emergency Department Patients With and Without Bacteremia

NCT05296590 | Active Not Recruiting DMC

• 1 other identifier: 14940
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief Summary

This project will evaluate the usefulness of Monocyte Distribution Width (MDW) for the diagnosis of blood culture positivity (BSI) in patients in the Emergency Department (ED) and reevaluate the usefulness of MDW in patients with BSI and sepsis. Consequently, if MDW indicate a high likelihood of bacteremia antibiotic management in patients with suspected bacterial infections will be changed and aid appropriate antibiotic administration.

Conditions

Bacteremia; Bacteremia Sepsis; Sepsis; Septic Shock; Severe Sepsis; Emergency Departments; Continuity of Patient Care

Keywords

Blood Stream Infection; BSI; Bacteremia; Sepsis; Severe Sepsis; Septic Shock; Emergency Departments; Continuity of Patient Care

Outcome Measures

Primary Outcomes (2)

• Observed Sensitivity and Specificity of MDW >/= 20 U in Emergency Department Patients with Positive Blood Cultures

  09/2020 to 02/2023

• Determine the negative predicative value of MDW assessments in Emergency Department patients at a cutoff threshold of <20 U in patients with negative blood cultures.

  09/2020 to 02/2023

Other Outcomes (6)

• Exploratory Aim 1 Explore the sensitivity and specificity of MDW measurement in samples excluded due to the consideration of contaminated blood culture. Contaminants could be considered for BSI with skin flora or singular positive blood cultures.

  09/2020 to 02/2023

• Exploratory Aim 2 Explore the sensitivity and specificity of MDW measurement in samples excluded due to use of antibiotics prior to the documented blood culture blood draw.

  09/2020 to 02/2023

• Exploratory Aim 3a Explore changes in size of MDW from ED presentation to the last available measurement prior to discharge as sign of resolution of infection or sepsis/ measurement of treatment response.

  09/2020 to 02/2023

Study Arms (4)

Positive Blood Culture/ Monocyte Distribution Width Normal

No intervention Monocyte Distribution Width considered normal (MDW less than 20 IU) in Emergency Department patients with Positive Blood Cultures. We will evaluate associated factors with this observation.

Diagnostic Test: Monocyte Distribution Width (MDW) , observation

Positive Blood Culture/ Monocyte Distribution Width Abnormal

No intervention Monocyte Distribution Width considered abnormal (MDW equal or greater than 20 IU) in Emergency Department patients with Positive Blood Cultures. We will evaluate associated factors with this observation.

Diagnostic Test: Monocyte Distribution Width (MDW) , observation

Negative Blood Culture/ Monocyte Distribution Width Normal

No intervention Monocyte Distribution Width considered normal (MDW less than 20 IU) in Emergency Department patients with negative Blood Cultures. We will evaluate associated factors with this observation.

Diagnostic Test: Monocyte Distribution Width (MDW) , observation

Negative Blood Culture/ Monocyte Distribution Width Abnormal

No intervention Monocyte Distribution Width considered abnormal (MDW equal or greater than 20 IU) in Emergency Department patients with negative Blood Cultures. We will evaluate associated factors with this observation.

Diagnostic Test: Monocyte Distribution Width (MDW) , observation

Interventions

Monocyte Distribution Width (MDW) , observation DIAGNOSTIC_TEST

Observation of MDW performance blinded to treating clinical teams

Negative Blood Culture/ Monocyte Distribution Width Abnormal; Negative Blood Culture/ Monocyte Distribution Width Normal; Positive Blood Culture/ Monocyte Distribution Width Abnormal; Positive Blood Culture/ Monocyte Distribution Width Normal

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

All Emergency Department patients older than 18 years with blood culture orders and blood culture blood draws.

You may qualify if:

• Patients in the Main Campus Emergency Department who had blood cultures ordered

You may not qualify if:

• Emergency Department Patients that do not have blood cultures ordered.

Sponsors & Collaborators

• Henry Ford Health System: lead
• Beckman Coulter, Inc.: collaborator

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (9)

• Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.

  PMID: 12682500 BACKGROUND

• Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; International Sepsis Definitions Conference. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Intensive Care Med. 2003 Apr;29(4):530-8. doi: 10.1007/s00134-003-1662-x. Epub 2003 Mar 28.

  PMID: 12664219 BACKGROUND

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Lo RSL, Leung LY, Brabrand M, Yeung CY, Chan SY, Lam CCY, Hung KKC, Graham CA. qSOFA is a Poor Predictor of Short-Term Mortality in All Patients: A Systematic Review of 410,000 Patients. J Clin Med. 2019 Jan 8;8(1):61. doi: 10.3390/jcm8010061.

  PMID: 30626160 BACKGROUND

• Crouser ED, Parrillo JE, Seymour C, Angus DC, Bicking K, Tejidor L, Magari R, Careaga D, Williams J, Closser DR, Samoszuk M, Herren L, Robart E, Chaves F. Improved Early Detection of Sepsis in the ED With a Novel Monocyte Distribution Width Biomarker. Chest. 2017 Sep;152(3):518-526. doi: 10.1016/j.chest.2017.05.039. Epub 2017 Jun 15.

  PMID: 28625579 BACKGROUND

• Crouser ED, Parrillo JE, Martin GS, Huang DT, Hausfater P, Grigorov I, Careaga D, Osborn T, Hasan M, Tejidor L. Monocyte distribution width enhances early sepsis detection in the emergency department beyond SIRS and qSOFA. J Intensive Care. 2020 May 5;8:33. doi: 10.1186/s40560-020-00446-3. eCollection 2020.

  PMID: 32391157 BACKGROUND

• Polilli E, Sozio F, Frattari A, Persichitti L, Sensi M, Posata R, Di Gregorio M, Sciacca A, Flacco ME, Manzoli L, Di Iorio G, Parruti G. Comparison of Monocyte Distribution Width (MDW) and Procalcitonin for early recognition of sepsis. PLoS One. 2020 Jan 10;15(1):e0227300. doi: 10.1371/journal.pone.0227300. eCollection 2020.

  PMID: 31923207 BACKGROUND

• Opota O, Jaton K, Greub G. Microbial diagnosis of bloodstream infection: towards molecular diagnosis directly from blood. Clin Microbiol Infect. 2015 Apr;21(4):323-31. doi: 10.1016/j.cmi.2015.02.005. Epub 2015 Feb 14.

  PMID: 25686695 BACKGROUND

• Fenollar F, Raoult D. Molecular diagnosis of bloodstream infections caused by non-cultivable bacteria. Int J Antimicrob Agents. 2007 Nov;30 Suppl 1:S7-15. doi: 10.1016/j.ijantimicag.2007.06.024. Epub 2007 Aug 17.

  PMID: 17707613 BACKGROUND

Related Links

• Abstract

MeSH Terms

Conditions

Bacteremia; Sepsis; Shock, Septic; Emergencies

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Study Officials

• Anja K Jaehne, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: July 1, 2021
• Primary Completion: December 31, 2023
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)