Differential Diagnostics of Etiology of Acute Infections

Neuroinfections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161951
• Other study ID #: RRPCEM_NMAT
• Status: Completed
• Start date: January 3, 2017
• Est. completion date: December 29, 2018

Study information

• Verified date: January 2019
• Source: The Republican Research and Practical Center for Epidemiology and Microbiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: December 29, 2018
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Intestinal Infectious Diseases
• Neuroinfections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Republican Research and Practical Center for Epidemiology and Microbiology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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