Improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy

December 14, 2018 updated by: Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology

Improved Basophil Activation Test (BAT) in the Diagnostics of IgE-mediated Drug Allergy

Current study evaluates the use of the improved Basophil Activation Test (BAT) in the diagnostics of IgE-mediated allergy to antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs).

Study Overview

Status

Unknown

Conditions

Detailed Description

Current study evaluates the use of the improved Basophil Activation Test (BAT) in the diagnostics of IgE-mediated allergy to antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs). Among commonly used CD63/CD203c markers, newly proposed molecules, such as CD69, CD107a, CD164, CD13, CD11b and CD300a will be assayed. Results obtained together with the other clinical data will be used to calculate sensitivity and specificity of the method.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220114
        • Andrei Hancharou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with the suspected allergy to antibiotics or NSAIDs

Description

Inclusion Criteria:

  • suspected allergy to antibiotics or NSAIDs in the last 1 year.

Exclusion Criteria:

  • autoimmune diseases;
  • HIV;
  • hepatitis B/C;
  • other acute or chronic infectious diseases;
  • malignant neoplasms;
  • leukemia;
  • other severe acute or chronic intercurrent diseases;
  • pregnancy/lactation;
  • refuse of patient to participate in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with drug allergy
Patients with drug allergy to antibiotics or NSAIDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of the improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy
Time Frame: 1 month
Sensitivity of the improved Basophil Activation Test (BAT) in the diagnostics of allergy to antibiotics or NSAIDs
1 month
Specificity of the improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy
Time Frame: 1 month
Specificity of the improved Basophil Activation Test (BAT) in the diagnostics of allergy to antibiotics or NSAIDs
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology

Investigators

  • Study Director: Andrei Hancharou, Dr, Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
  • Principal Investigator: Iryna U Ramanava, Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 3, 2017

Primary Completion (ACTUAL)

December 11, 2018

Study Completion (ANTICIPATED)

June 30, 2019

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (ACTUAL)

May 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2018

Last Update Submitted That Met QC Criteria

December 14, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRPCEM_BAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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