BacteremiaNCT05296590
Monocyte Distribution Width (MDW) in the General Population of Emergency Department Patients With and Without Bacteremia
An observational study of Bacteremia and Bacteremia Sepsis, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia, Bacteremia Sepsis, Sepsis
- What is being tested?
- Monocyte Distribution Width (MDW) , observation
- How many people
- 50,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All Emergency Department patients older than 18 years with blood culture orders and blood culture blood draws.
Who may be able to join
- Patients in the Main Campus Emergency Department who had blood cultures ordered
Who cannot join
- Emergency Department Patients that do not have blood cultures ordered.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
BIOMARKERS for Sepsis and Infection should address important clinical aspects such as
- Rapid diagnosis of invasive infections contributing to organ dysfunction;
- Provide information regarding antibiotic susceptibility and
- Distinguish infection mediated organ dysfunction from non-infectious sepsis mimics.
Review of MDW values for ED patients who have positive blood cultures The gold standard for the diagnosis of bloodstream infections is positive blood cultures. Not all patients with sepsis have positive blood cultures, however patients with blood stream infections and end-organ dysfunction are septic and need to be treated with antibiotics. Two definitions of sepsis currently are used.
The sepsis-2 definitions [1,2] are based on a confirmed or suspected infectious source, a systemic response with two or more abnormal systemic inflammatory response syndrome criteria such as hyper or hypothermia, tachycardia, tachypnea and leukopenia or leukocytosis or bandemia and signs of at least one new end organ dysfunction. There is a differentiation between different degrees of disease severity between sepsis, severe sepsis and septic shock. Each of these degrees of illness severity are associated with different morbidity and mortality.
The sepsis-3 definition [3] state that sepsis is the bodies response to an infectious agent. The response is assessed using a quick SOFA score (qSOFA) assessment based on tachypnea of equal or greater than 22 breath, systolic hypotension of equal or less than 100 mmHg and changes in mentation measured by a Glasgow Coma Score (GCS) of less than 15 along with the requirement of a new onset of organ dysfunction as measured by a SOFA score of equal or greater than 2.[4] Sepsis-3 definition distinguish between sepsis and septic shock only. Septic shock is only present if a patient has 2 or more qSOFA criteria, requires the use of a vasoactive agent to maintain a mean arterial blood pressure of 70 mmHg AND if the lactate is greater than 2 mg/dL. Patients which do not have a qSOFA score of greater than 2 or a SOFA score of less than 2 are considered not septic and as having only a local infection.
Both definitions have the requirement for a proven or suspected infection. Source identification is important, however not always successful. The most common site of infection is the lung. This infection is most commonly viral or bacterial. The second most common site of infection is the genitourinary tract followed by blood stream infections. The diagnosis of blood stream infections (BSI) can be affected by a variety of factors including the collection technique to avoid contamination, the amount of blood volume collected, the timing of collection among other factors. Specifically, the early recognition of blood culture positivity and appropriate early source control are essential for successful treatment of patients with signs of a systemic response to the blood stream infection and end-organ dysfunction. Delay in recognition of blood culture positivity can lead to treatment delays along with possible disease progression.
Studies evaluated the usefulness of monocyte distribution width (MDW) for the assessment of emergency department patients with sepsis. It has been observed that monocyte activation in response to bacteremia leads to increased monocyte size. [5] MDW reflects a measure of a change in the size distribution of circulating monocytes. MDW has been evaluated for the aid of sepsis based on the definitions above. [6] The study by Crouser showed that the detection diagnosis of sepsis within 12 hours of ED presentation was aided when MDW was added. Similar, Polili et al found that the addition of MDW to the routine White Blood Cell (WBC) counts aids sepsis diagnosis and may be more useful than procalcitonin. [7]
It has not yet clearly established that MDW are elevated in bloodstream infections (BSI). BSI are diagnosed using blood cultures as gold standard for diagnosis. Blood cultures have a high sensitivity and specificity.[8] Up to thirty forty percent of septic shock patients will be blood culture positive and up to 25-30% negative for any type of culture. However, the diagnosis can take time delaying initiation of appropriate treatment. Additionally, in up to 50 % of cases BSI may be present without blood culture positivity due to the presence of uncultivable organisms or antibiotic treatment started prior to sampling.[9] MDW may be useful in not only aiding the diagnosis of sepsis but also in the expedited diagnosis of BSI.
This project will evaluate the usefulness of MDW for the diagnosis of blood culture positivity (BSI) in patients in the 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. On the other hand, a negative MDW test in the ED without additional risk factors or signs of infection (ie. Urinary tract, pneumonia, skin) or suspected severe sepsis or septic shock, patients may be treated supportively without use of antibiotics in the appropriate clinical setting.
- Conditions
- Bacteremia, Bacteremia Sepsis, Sepsis, Septic Shock, Severe Sepsis, Emergency Departments
- Being tested
- Monocyte Distribution Width (MDW) , observation
- Keywords
- Blood Stream Infection, BSI, Bacteremia, Sepsis, Severe Sepsis, Septic Shock, Emergency Departments, Continuity of Patient Care
- Medical subject headings
- Bacteremia, Sepsis, Shock, Septic, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monocyte Distribution Width (MDW) , observationDiagnostic test
Observation of MDW performance blinded to treating clinical teams
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Monocyte Distribution Width (MDW) , observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Sensitivity and Specificity of MDW >/= 20 U in Emergency Department Patients with Positive Blood Cultures
Measured: 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.
Measured: 09/2020 to 02/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Jul 2021
- Primary completion31 Dec 2023
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Coulter, Inc.
- Responsible party
- Principal investigator, Anja Kathrin Jaehne, Henry Ford Health System
- Investigators
- Anja K Jaehne, MD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296590
- Sponsor's protocol ID
- 14940
- Status last verified
- May 2026
- First submitted
- 16 Mar 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share individual subject data for privacy reasons. We plan to share aggregate data.
Publications
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.
PubMed 12682500Levy 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.
PubMed 12664219Singer 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.
PubMed 26903338Lo 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.
PubMed 30626160Crouser 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.
PubMed 28625579Crouser 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.
PubMed 32391157Polilli 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.
PubMed 31923207Opota 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.
PubMed 25686695Fenollar 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.
PubMed 17707613
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocyte Distribution Width (MDW) in the General Population of Emergency Department Patients With and Without Bacteremia
- ClinicalTrials.gov ID
- NCT05296590
- Acronym / sponsor ID
- 14940
- Conditions
- Bacteremia, Bacteremia Sepsis, Sepsis, Septic Shock, Severe Sepsis, Emergency Departments
- Keywords
- Blood Stream Infection, BSI, Bacteremia, Sepsis, Severe Sepsis, Septic Shock, Emergency Departments, Continuity of Patient Care
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Beckman Coulter, Inc.
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Mar 2022 (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 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.
Detailed description
BIOMARKERS for Sepsis and Infection should address important clinical aspects such as
- Rapid diagnosis of invasive infections contributing to organ dysfunction;
- Provide information regarding antibiotic susceptibility and
- Distinguish infection mediated organ dysfunction from non-infectious sepsis mimics.
Review of MDW values for ED patients who have positive blood cultures The gold standard for the diagnosis of bloodstream infections is positive blood cultures. Not all patients with sepsis have positive blood cultures, however patients with blood stream infections and end-organ dysfunction are septic and need to be treated with antibiotics. Two definitions of sepsis currently are used.
The sepsis-2 definitions [1,2] are based on a confirmed or suspected infectious source, a systemic response with two or more abnormal systemic inflammatory response syndrome criteria such as hyper or hypothermia, tachycardia, tachypnea and leukopenia or leukocytosis or bandemia and signs of at least one new end organ dysfunction. There is a differentiation between different degrees of disease severity between sepsis, severe sepsis and septic shock. Each of these degrees of illness severity are associated with different morbidity and mortality.
The sepsis-3 definition [3] state that sepsis is the bodies response to an infectious agent. The response is assessed using a quick SOFA score (qSOFA) assessment based on tachypnea of equal or greater than 22 breath, systolic hypotension of equal or less than 100 mmHg and changes in mentation measured by a Glasgow Coma Score (GCS) of less than 15 along with the requirement of a new onset of organ dysfunction as measured by a SOFA score of equal or greater than 2.[4] Sepsis-3 definition distinguish between sepsis and septic shock only. Septic shock is only present if a patient has 2 or more qSOFA criteria, requires the use of a vasoactive agent to maintain a mean arterial blood pressure of 70 mmHg AND if the lactate is greater than 2 mg/dL. Patients which do not have a qSOFA score of greater than 2 or a SOFA score of less than 2 are considered not septic and as having only a local infection.
Both definitions have the requirement for a proven or suspected infection. Source identification is important, however not always successful. The most common site of infection is the lung. This infection is most commonly viral or bacterial. The second most common site of infection is the genitourinary tract followed by blood stream infections. The diagnosis of blood stream infections (BSI) can be affected by a variety of factors including the collection technique to avoid contamination, the amount of blood volume collected, the timing of collection among other factors. Specifically, the early recognition of blood culture positivity and appropriate early source control are essential for successful treatment of patients with signs of a systemic response to the blood stream infection and end-organ dysfunction. Delay in recognition of blood culture positivity can lead to treatment delays along with possible disease progression.
Studies evaluated the usefulness of monocyte distribution width (MDW) for the assessment of emergency department patients with sepsis. It has been observed that monocyte activation in response to bacteremia leads to increased monocyte size. [5] MDW reflects a measure of a change in the size distribution of circulating monocytes. MDW has been evaluated for the aid of sepsis based on the definitions above. [6] The study by Crouser showed that the detection diagnosis of sepsis within 12 hours of ED presentation was aided when MDW was added. Similar, Polili et al found that the addition of MDW to the routine White Blood Cell (WBC) counts aids sepsis diagnosis and may be more useful than procalcitonin. [7]
It has not yet clearly established that MDW are elevated in bloodstream infections (BSI). BSI are diagnosed using blood cultures as gold standard for diagnosis. Blood cultures have a high sensitivity and specificity.[8] Up to thirty forty percent of septic shock patients will be blood culture positive and up to 25-30% negative for any type of culture. However, the diagnosis can take time delaying initiation of appropriate treatment. Additionally, in up to 50 % of cases BSI may be present without blood culture positivity due to the presence of uncultivable organisms or antibiotic treatment started prior to sampling.[9] MDW may be useful in not only aiding the diagnosis of sepsis but also in the expedited diagnosis of BSI.
This project will evaluate the usefulness of MDW for the diagnosis of blood culture positivity (BSI) in patients in the 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. On the other hand, a negative MDW test in the ED without additional risk factors or signs of infection (ie. Urinary tract, pneumonia, skin) or suspected severe sepsis or septic shock, patients may be treated supportively without use of antibiotics in the appropriate clinical setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Positive Blood Culture/ Monocyte Distribution Width Normal | – | Diagnostic Test: Monocyte Distribution Width (MDW) , observationNo 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. |
| Positive Blood Culture/ Monocyte Distribution Width Abnormal | – | Diagnostic Test: Monocyte Distribution Width (MDW) , observationNo 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. |
| Negative Blood Culture/ Monocyte Distribution Width Normal | – | Diagnostic Test: Monocyte Distribution Width (MDW) , observationNo 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. |
| Negative Blood Culture/ Monocyte Distribution Width Abnormal | – | Diagnostic Test: Monocyte Distribution Width (MDW) , observationNo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Emergency Department patients older than 18 years with blood culture orders and blood culture blood draws.
Key inclusion criteria (1 listed)
- Patients in the Main Campus Emergency Department who had blood cultures ordered
Key exclusion criteria (1 listed)
- Emergency Department Patients that do not have blood cultures ordered.
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 |
|---|---|---|
| Monocyte Distribution Width (MDW) , observationObservation of MDW performance blinded to treating clinical teams | Diagnostic test | 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 |
Primary outcome
Observed Sensitivity and Specificity of MDW >/= 20 U in Emergency Department Patients with Positive Blood Cultures
Time frame: 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.
Time frame: 09/2020 to 02/2023
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 12682500Levy 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.
- Background: PubMed 12664219Levy 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.
- Background: PubMed 26903338Singer 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.
- Background: PubMed 30626160Lo 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.
- Background: PubMed 28625579Crouser 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.
- Background: PubMed 32391157Crouser 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.
- Background: PubMed 31923207Polilli 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.
- Background: PubMed 25686695Opota 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.
- Background: PubMed 17707613Fenollar 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.
- AbstractLink provided by the sponsor.
- Individual participant dataSharing planned: No. We will not share individual subject data for privacy reasons. We plan to share aggregate data.
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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.
Anja K Jaehne, MD principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia and Bacteremia Sepsis, run by Henry Ford Health System at 1 site in United States.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Observed Sensitivity and Specificity of MDW >/= 20 U in Emergency Department Patients with Positive Blood Cultures (time frame: 09/2020 to 02/2023). 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?
On the ClinicalTrials.gov record for NCT05296590, which also lists 9 linked publications.
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 12 May 2026.