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

NCT ID: NCT03164044

Last Updated: 2018-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-03

Study Completion Date

2019-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Drug Allergy Antibiotic Allergy NSAID-Induced Anaphylactoid Reaction

Keywords

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Allergy Drug allergy Basophil activation test Flow cytometry

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with drug allergy

Patients with drug allergy to antibiotics or NSAIDs

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Republican Research and Practical Center for Epidemiology and Microbiology

OTHER

Sponsor Role lead

Responsible Party

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Andrei Y. Hancharou

Head of the Laboratory for Immunology and Cellular Biotechnology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrei Hancharou, Dr

Role: STUDY_DIRECTOR

Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

Iryna U Ramanava

Role: PRINCIPAL_INVESTIGATOR

Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

Locations

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Andrei Hancharou

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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RRPCEM_BAT

Identifier Type: -

Identifier Source: org_study_id