Differential Diagnostics of Etiology of Acute Infections

NCT03161951 | Completed

• 1 other identifier: RRPCEM_NMAT
• Study Type: observational
• Target: 169
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intestinal Infectious Diseases; Neuroinfections

Keywords

acute Infections, flow cytometry, cell activation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the infectious departments of city hospitals.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Republican Research and Practical Center for Epidemiology and Microbiology: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

Study Officials

• Andrei Y Hancharou, Dr

  Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Laboratory for Immunology and Cellular Biotechnology,

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 22, 2017
• Study Start: January 3, 2017
• Primary Completion: December 10, 2018
• Study Completion: December 29, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share