Differential Diagnostics of Etiology of Acute Infections

Completed

• Conditions: Intestinal Infectious Diseases; Neuroinfections

• Registration Number: NCT03161951
• Lead Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology

Brief Summary

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.

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 Timeline

• Study Start: 2017-01-03
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-22
• Primary Completion: 2018-12-10
• Study Completion: 2018-12-29
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of the diagnosis of bacterial vs viral acute infection	1 month	Sensitivity of the diagnosis of bacterial vs viral acute infection using proposed method
Specificity of the diagnosis of bacterial vs viral acute infection	1 month	Specificity of the diagnosis of bacterial vs viral acute infection using proposed method