Drug HypersensitivityNCT06523192
Validation of the English Version of the Drug Hypersensitivity Quality of Life Questionnaire
An observational study of Drug Hypersensitivity and Quality of Life, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Hypersensitivity, Quality of Life
- What is being tested?
- Questionnaires
- How many people
- 146 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Mar 2023to 1 May 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Our target population are patients with diagnosed drug allergy.
Who may be able to join
- • Age >18 years
- Ability to read English and consent.
- Confirmed diagnosis of a drug hypersensitivity reaction.
- Written informed consent
Who cannot join
- • < 18y/o.
- Not able to read English. No mental capacity to consent or unwilling to consent.
- Unconfirmed diagnosis of a drug hypersensitivity reaction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The English Version of the Drug Hypersensitivity Quality of Life Questionnaire: Validity and Reliability in the British Population.
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?
- Conditions
- Drug Hypersensitivity, Quality of Life
- Being tested
- Questionnaires
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the English version of the Drug Hypersensitivity Questionnaire
Reliability and validity
Measured: March 2023 May 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start21 Mar 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug HypersensitivityStudies 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523192
- Sponsor's protocol ID
- 151058
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- 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 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The English Version of the Drug Hypersensitivity Quality of Life Questionnaire: Validity and Reliability in the British Population.
- ClinicalTrials.gov ID
- NCT06523192
- Acronym / sponsor ID
- 151058
- Conditions
- Drug Hypersensitivity, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 26 Jul 2024 (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.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Our target population are patients with diagnosed drug allergy.
Key inclusion criteria (4 listed)
- • Age >18 years
Key exclusion criteria (3 listed)
- • < 18y/o.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesNo intervention | Other | – |
Primary outcome
Validation of the English version of the Drug Hypersensitivity Questionnaire
Time frame: March 2023 May 2024
Reliability and validity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypersensitivity and Quality of Life, run by University Hospitals, Leicester at 1 site in United Kingdom.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 26 Jul 2024. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Validation of the English version of the Drug Hypersensitivity Questionnaire (time frame: March 2023 May 2024). 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 26 Jul 2024.