How to quickly determine the severity of an infectious disease from a complete blood count?

Not Applicable

Completed

• Conditions: Evaluation of monocyte distribution width for early detection of sepsis; Haematological Disorders

• Registration Number: ISRCTN13887392
• Lead Sponsor: Beckman Coulter

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-12-31
• Study Start: 2023-11-07
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1925

Inclusion Criteria

All consecutive adults presenting to the Emergency department and subsequently admitted to the hospital (medical ward or intensive care unit) and for whom complete blood count with differential is ordered upon presentation will be included into the study. Patients will be categorized into several pre-defined groups:
1. Patients with and without infections regardless the presence of SIRS criteria;
2. Patients with definitive diagnosis of infection or sepsis (defined according to Sepsis-3 criteria) will further be subdivided in clinically documented infection/sepsis and microbiologically documented infection/sepsis;
3. Microbiologically documented infection/sepsis will further be subdivided into bacterial and non-bacterial infections depending on the type of germ cultured or identified otherwise (PCR etc.);
4. Patients with infection will be compared to patients fulfilling criteria for sepsis or septic shock;
5. Patients will also be categorized into infected-SIRS and non-infected SIRS groups and analyzed separately.

Exclusion Criteria

1. Previously enrolled in this study (i.e. subjects may not be enrolled more than once in this study)
2. Subjects discharged from the ED
3. Subjects with CRP and PCT not performed
4. Pregnant women
5. Relevant limitations of therapy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The following primary outcome measures are assessed using medical records and blood collected at the time of the emergency department visit:<br> 1. Diagnostic performance of monocyte distribution width (MDW) in adult patients with community-acquired uncomplicated infections, sepsis and septic shock measured using a UniCelDxH 900 analyzer (Beckman Coulter, Inc., Brea, CA) using blood collected at the time of the emergency department visit<br> 2. C-reactive protein measured using standard methods in all patients<br> 3. Procalcitonin measured using standard methods when clinically indicated<br><br>

Secondary Outcome Measures

Name	Time	Method
<br> The following secondary outcome measures are measured using medical records and blood collected at the time of the emergency department visit:<br> 1. Sources of heterogeneity in the estimates of diagnostic accuracy (e.g. immunosuppression, cancer, autoimmunity, chronic comorbidities, etc.)<br> 2. The influence of different types of pathogens (e.g. gram-positive, gram-negative, fungal, viral) and sites of infection on MDW<br> 3. Diagnostic accuracy of MDW in the distinction of sepsis from non-infectious conditions<br>