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Differential Diagnostics of Etiology of Acute Infections

Sponsor
The Republican Research and Practical Center for Epidemiology and Microbiology (Other)
Overall Status
Completed
CT.gov ID
NCT03161951
Collaborator
(none)
169
Enrollment
23.8
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    169 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    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.
    Actual Study Start Date :
    Jan 3, 2017
    Actual Primary Completion Date :
    Dec 10, 2018
    Actual Study Completion Date :
    Dec 29, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrei Y. Hancharou, Head of the Laboratory for Immunology and Cellular Biotechnology,, The Republican Research and Practical Center for Epidemiology and Microbiology
    ClinicalTrials.gov Identifier:
    NCT03161951
    Other Study ID Numbers:
    • RRPCEM_NMAT
    First Posted:
    May 22, 2017
    Last Update Posted:
    Jan 9, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Andrei Y. Hancharou, Head of the Laboratory for Immunology and Cellular Biotechnology,, The Republican Research and Practical Center for Epidemiology and Microbiology
    acute Infections, flow cytometry, cell activation
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases

    Study Results

    No Results Posted as of Jan 9, 2019