ClinicalTrials.gg
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this record recently (last verified Dec 2018), so the status shown — last known as Enrolling by invitation — may be out of date.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

In context

Drug Hypersensitivity

57 studies on the registry are indexed under Drug Hypersensitivity; 18 are open to participants now.

This study's enrollment of 45 is below the median of 204 across 30 observational studies indexed under Drug Hypersensitivity.

Browse Drug Hypersensitivity studies →

Lead sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • diseases;
  • ;
  • /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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

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

06

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

07

Study locations

1 site
  • Andrei Hancharou
    Minsk, 220114, Belarus
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Dec 2018, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2017
First posted
May 23, 2017
StartActual
Jan 3, 2017
Primary completionActual
Dec 11, 2018
CompletionEst.
Jun 30, 2019
Last update
Dec 17, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

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