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

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ClinicalTrials.gov Identifier: NCT03164044
Recruitment Status : Enrolling by invitation
First Posted : May 23, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Andrei Y. Hancharou, 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).

Condition or disease
Drug Allergy Antibiotic Allergy NSAID-Induced Anaphylactoid Reaction

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
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improved Basophil Activation Test (BAT) in the Diagnostics of IgE-mediated Drug Allergy
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples Without DNA
Whole blood drained into tubes with sodium heparin


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with the suspected allergy to antibiotics or NSAIDs
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164044


Locations
Belarus
Andrei Hancharou
Minsk, Belarus, 220114
Sponsors and Collaborators
The Republican Research and Practical Center for Epidemiology and Microbiology
Investigators
Study Director: Andrei Hancharou, Dr Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Informed consent form [In Russian]
Brief test protocol [In Russian]  This link exits the ClinicalTrials.gov site
Brief test protocol [In Russian]

Responsible Party: Andrei Y. Hancharou, Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
ClinicalTrials.gov Identifier: NCT03164044     History of Changes
Other Study ID Numbers: RRPCEM_BAT
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology:
Allergy
Drug allergy
Basophil activation test
Flow cytometry

Additional relevant MeSH terms:
Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders