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Status unknownNCT03164044Updated Dec 17, 2018

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

An observational study in Drug Allergy, Antibiotic Allergy and NSAID-Induced Anaphylactoid Reaction, sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology. Status unknown at 1 site in Belarus. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-12-17.

Sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology · Observational

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
45
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

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

Keywords

  • Allergy
  • Drug allergy
  • Basophil activation test
  • Flow cytometry
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with the suspected allergy to antibiotics or NSAIDs

Inclusion criteria

  • suspected allergy to antibiotics or NSAIDs in the last 1 year.

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients with drug allergy

    Patients with drug allergy to antibiotics or NSAIDs

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 month

  2. 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

    Time frame: 1 month

06

Study locations

1 site
  • Andrei Hancharou
    Minsk, 220114, Belarus
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03164044
Lead sponsor
The Republican Research and Practical Center for Epidemiology and Microbiology
Responsible party
Andrei Y. Hancharou (Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology) — Principal investigator
First posted
May 23, 2017
Start date
Jan 3, 2017
Primary completion
Dec 11, 2018
Completion
Jun 30, 2019 (estimated)
Last update
Dec 17, 2018

Study contacts

Andrei Hancharou, Dr
study director · Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
Iryna U Ramanava
principal investigator · Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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