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

Drug Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03164044
• Other study ID #: RRPCEM_BAT
• Status: Enrolling by invitation
• Start date: January 3, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2018
• Source: The Republican Research and Practical Center for Epidemiology and Microbiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: June 30, 2019
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Allergy
• Drug Allergy
• Drug Hypersensitivity
• Hypersensitivity
• NSAID-Induced Anaphylactoid Reaction

Locations

Country	Name	City	State
Belarus	Andrei Hancharou	Minsk

Sponsors (1)

Lead Sponsor	Collaborator
The Republican Research and Practical Center for Epidemiology and Microbiology

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy	Sensitivity of the improved Basophil Activation Test (BAT) in the diagnostics of allergy to antibiotics or NSAIDs	1 month
Primary	Specificity of the improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy	Specificity of the improved Basophil Activation Test (BAT) in the diagnostics of allergy to antibiotics or NSAIDs	1 month