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Differential Diagnostics of Etiology of Acute Infections

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03161951
First Posted: May 22, 2017
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology
  Purpose
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
Intestinal Infectious Diseases Neuroinfections

Study Type: Observational
Study Design: Observational Model: Cohort
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.

Further study details as provided by Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology:

Primary Outcome Measures:
  • Sensitivity of the diagnosis of bacterial vs viral acute infection [ Time Frame: 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 [ Time Frame: 1 month ]
    Specificity of the diagnosis of bacterial vs viral acute infection using proposed method


Biospecimen Retention:   Samples Without DNA
Whole blood

Estimated Enrollment: 100
Actual Study Start Date: January 3, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: August 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Neuroinfections
Patients with acute neuroinfections of bacterial and viral ethology.
Intestinal Infectious Diseases
Patients with acute intestinal infectious diseases of bacterial and viral ethology.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the infectious departments of city hospitals.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161951


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
  More Information

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Informed consent form (in Russian)
Study Protocol  This link exits the ClinicalTrials.gov site
Sample preparation form (in Russian)

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     History of Changes
Other Study ID Numbers: RRPCEM_NMAT
First Submitted: May 17, 2017
First Posted: May 22, 2017
Last Update Posted: May 22, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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, The Republican Research and Practical Center for Epidemiology and Microbiology:
acute Infections, flow cytometry, cell activation

Additional relevant MeSH terms:
Infection
Communicable Diseases