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Completed

NCT Number: NCT03161951

Differential Diagnostics of Etiology of Acute Infections

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.

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 22, 2017
Registry last updated
Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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