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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03164044
First Posted: May 23, 2017
Last Update Posted: May 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology
  Purpose
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
Drug Allergy Antibiotic Allergy NSAID-Induced Anaphylactoid Reaction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improved Basophil Activation Test (BAT) in the Diagnostics of IgE-mediated Drug Allergy

Resource links provided by NLM:


Further study details as provided by Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology:

Primary Outcome Measures:
  • 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

  • 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

Estimated Enrollment: 100
Actual Study Start Date: January 3, 2017
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with drug allergy
Patients with drug allergy to antibiotics or 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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.
  Contacts and Locations
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
  More Information

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 Submitted: May 22, 2017
First Posted: May 23, 2017
Last Update Posted: May 24, 2017
Last Verified: May 2017
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