Drug AllergyNCT03164044
Improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy
An observational study of Drug Allergy and Antibiotic Allergy, run by The Republican Research and Practical Center for Epidemiology and Microbiology at 1 site in Belarus.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Drug Allergy, Antibiotic Allergy, NSAID-Induced Anaphylactoid Reaction
- How many people
- 45 participants
- Where
- 1 siteBelarus
- Study dates
- 3 Jan 2017to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with the suspected allergy to antibiotics or NSAIDs
Who may be able to join
- suspected allergy to antibiotics or NSAIDs in the last 1 year.
Who cannot join
- autoimmune diseases;
- HIV;
- hepatitis B/C;
- other acute or chronic infectious diseases;
- malignant neoplasms;
- leukemia;
Show all 9Show fewer
- other severe acute or chronic intercurrent diseases;
- pregnancy/lactation;
- refuse of patient to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Basophil Activation Test (BAT) in the Diagnostics of IgE-mediated Drug Allergy
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.
- Keywords
- Allergy, Drug allergy, Basophil activation test, Flow cytometry
- Medical subject headings
- Drug Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with drug allergy | Patients with drug allergy to antibiotics or NSAIDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start3 Jan 2017
- Primary completion11 Dec 2018
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Republican Research and Practical Center for Epidemiology and Microbiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology
- Investigators
- Andrei Hancharou, Dr, Study director, Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and MicrobiologyIryna U Ramanava, Principal investigator, Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164044
- Sponsor's protocol ID
- RRPCEM_BAT
- Status last verified
- Dec 2018
- First submitted
- 22 May 2017
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Basophil Activation Test (BAT) in the Diagnostics of IgE-mediated Drug Allergy
- ClinicalTrials.gov ID
- NCT03164044
- Acronym / sponsor ID
- RRPCEM_BAT
- Keywords
- Allergy, Drug allergy, Basophil activation test, Flow cytometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The Republican Research and Practical Center for Epidemiology and MicrobiologyUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with drug allergy | – | –Patients with drug allergy to antibiotics or NSAIDs |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the suspected allergy to antibiotics or NSAIDs
Key inclusion criteria (1 listed)
- suspected allergy to antibiotics or NSAIDs in the last 1 year.
Key exclusion criteria (9 listed)
- autoimmune diseases;
- HIV;
- hepatitis B/C;
- other acute or chronic infectious diseases;
- malignant neoplasms;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Allergy and Antibiotic Allergy, run by The Republican Research and Practical Center for Epidemiology and Microbiology at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.