Differential Diagnostics of Etiology of Acute Infections

Differential Diagnostics of Etiology of Acute Infections Based on the Analysis of Expression of Activation Markers on the Surface of Peripheral Blood Monocytes and Neutrophils.

Method for diagnostics of the origin of infections (bacterial vs viral) based on the identification of activation markers of blood neutrophils and monocytes will be developed.

Study Overview

• Status: Completed
• Conditions: Intestinal Infectious Diseases; Neuroinfections

Detailed Description

During the study, method for diagnostics of the origin of infections (bacterial vs viral) based on the identification of activation markers of blood neutrophils and monocytes will be developed.This method will allow to make a diagnosis within an hour after blood sampling.

The expression of the following markers of activation will be studied using flow cytometry: CD11b, CD11c, CD13, CD16, CD32, CD35, CD38, CD62L, CD64, CD66b, CD88, CD284, HLA-ABC and HLA-DR.

• Study Type: Observational
• Enrollment (Actual): 169

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the infectious departments of city hospitals.

Description

Inclusion Criteria:

• neuroinfections or acute intestinal infections;
• the possibility of blood sampling within a period of up to 24 hours from the moment of admission to hospital;
• less than 72 hours passed after the onset of the disease and until blood was collected;

Exclusion Criteria:

• refuse of patient to participate in the trial;
• more than 24 hours passed after the patient entered the hospital;
• the disease began more than 72 hours ago;
• concomitant severe acute and chronic diseases;
• malignant neoplasms, treatment at a time of less than 1 year, autoimmune diseases in the phase of exacerbation;
• pregnancy/lactation;
• HIV, Hepatites B/C;
• active tuberculosis;
• alcohol use disorder/drug addiction.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Neuroinfections; Patients with acute neuroinfections of bacterial and viral ethology.
Intestinal Infectious Diseases; Patients with acute intestinal infectious diseases of bacterial and viral ethology.
Control group; Control group of healthy persons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the diagnosis of bacterial vs viral acute infection	Sensitivity of the diagnosis of bacterial vs viral acute infection using proposed method	1 month
Specificity of the diagnosis of bacterial vs viral acute infection	Specificity of the diagnosis of bacterial vs viral acute infection using proposed method	1 month

Collaborators and Investigators

• Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology
• Investigators: Study Director: Andrei Y Hancharou, Dr, Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2017
• Primary Completion (Actual): December 10, 2018
• Study Completion (Actual): December 29, 2018

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: acute Infections, flow cytometry, cell activation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: RRPCEM_NMAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No