NCT03164044

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

December 17, 2018

Status Verified

December 1, 2018

Enrollment Period

1.9 years

First QC Date

May 22, 2017

Last Update Submit

December 14, 2018

Conditions

Drug AllergyAntibiotic AllergyNSAID-Induced Anaphylactoid Reaction

Keywords

AllergyDrug allergyBasophil activation testFlow cytometry

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    1 month

Study Arms (1)

Patients with drug allergy

Patients with drug allergy to antibiotics or NSAIDs

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with the suspected allergy to antibiotics or NSAIDs

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrei Hancharou

Minsk, 220114, Belarus

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood drained into tubes with sodium heparin

MeSH Terms

Conditions

Drug HypersensitivityHypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersImmune System Diseases

Study Officials

  • Andrei Hancharou, Dr

    Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

    STUDY DIRECTOR

  • Iryna U Ramanava

    Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Laboratory for Immunology and Cellular Biotechnology

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 23, 2017

Study Start

January 3, 2017

Primary Completion

December 11, 2018

Study Completion

June 30, 2019

Last Updated

December 17, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)