ClinicalTrials.gg
CompletedNCT03161951Updated Jan 9, 2019

Differential Diagnostics of Etiology of Acute Infections

An observational study in Intestinal Infectious Diseases and Neuroinfections, sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
169
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Intestinal Infectious Diseases
  • Neuroinfections

Keywords

  • acute Infections, flow cytometry, cell activation
03

In context

Lead sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients admitted to the infectious departments of city hospitals.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, diseases in the phase of exacerbation;
  • pregnancy/lactation;
  • , Hepatites B/C;
  • active tuberculosis;
  • alcohol use disorder/drug addiction.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
169 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and 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.

  • Control group

    Control group of healthy persons

06

What researchers measure

Primary outcomes

  1. Sensitivity of the diagnosis of bacterial vs viral acute infection

    Sensitivity of the diagnosis of bacterial vs viral acute infection using proposed method

    Time frame: 1 month

  2. Specificity of the diagnosis of bacterial vs viral acute infection

    Specificity of the diagnosis of bacterial vs viral acute infection using proposed method

    Time frame: 1 month

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Dec 2018, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2017
First posted
May 22, 2017
StartActual
Jan 3, 2017
Primary completionActual
Dec 10, 2018
CompletionActual
Dec 29, 2018
Last update
Jan 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03161951
Lead sponsor
The Republican Research and Practical Center for Epidemiology and Microbiology
Responsible party
Andrei Y. Hancharou (Head of the Laboratory for Immunology and Cellular Biotechnology,, The Republican Research and Practical Center for Epidemiology and Microbiology) — Principal investigator
First posted
May 22, 2017
Start date
Jan 3, 2017
Primary completion
Dec 10, 2018
Completion
Dec 29, 2018
Last update
Jan 9, 2019

Study contacts

Andrei Y Hancharou, Dr
study director · Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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