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

• Conditions: Drug Allergy; NSAID-Induced Anaphylactoid Reaction; Antibiotic Allergy

• Registration Number: NCT03164044
• Lead Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology

Brief Summary

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

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 Timeline

• Study Start: 2017-01-03
• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-23
• Status Verified: 2018-12
• Primary Completion: 2018-12-11
• Last Update Submitted: 2018-12-14
• Last Update Posted: 2018-12-17
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of the improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy	1 month	Sensitivity of the improved Basophil Activation Test (BAT) in the diagnostics of allergy to antibiotics or NSAIDs
Specificity of the improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy	1 month	Specificity of the improved Basophil Activation Test (BAT) in the diagnostics of allergy to antibiotics or NSAIDs

Trial Locations

Locations (1)

Andrei Hancharou; 🇧🇾 Minsk, Belarus