NCT06523192

Brief Summary

We aim to validate the English (UK) translation of the DrHy-Q, and test its reliability in the UK population. This will facilitate for the subsequent economical evaluation of penicillin allergy delabelling. This research project is part of an MSc in Allergy undertaken by the principal applicant, Dr Patricia Romero, supervised through Imperial College London. Target population are patients with a drug allergy diagnosed by an Allergist prospectively at the Drug Allergy Clinic. Is the English version of the Drug Hypersensitivity Quality of Life Questionnaire suitable to be used in the UK population?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

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

March 21, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

July 22, 2024

Last Update Submit

July 22, 2024

Conditions

Drug HypersensitivityQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Validation of the English version of the Drug Hypersensitivity Questionnaire

    Reliability and validity

    March 2023 May 2024

Interventions

QuestionnairesOTHER

No intervention

Eligibility Criteria

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

Our target population are patients with diagnosed drug allergy.

You may qualify if:

  • Age \>18 years
  • Ability to read English and consent.
  • Confirmed diagnosis of a drug hypersensitivity reaction.
  • Written informed consent

You may not qualify if:

  • \< 18y/o.
  • Not able to read English. No mental capacity to consent or unwilling to consent.
  • Unconfirmed diagnosis of a drug hypersensitivity reaction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNiversity Hospitals Leicester

Leicester, LE39QP, United Kingdom

Location

MeSH Terms

Conditions

Drug Hypersensitivity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 26, 2024

Study Start

March 21, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)