Penicillin AllergyDe-Label MeNCT06532448
Evaluating the Feasibility of High-volume, Low-risk Penicillin Allergy De-labelling to Maximise Efficiency in a Resource-limited Setting
A study testing Single dose low-risk penicillin challenge in people with Penicillin Allergy, run by University Hospital Southampton NHS Foundation Trust.
Trial summary
Plenty of studies have now established the safety of low-risk penicillin allergy de-labelling, but few have addressed how to organise de-labelling at the clinic level. This study will test the real world practicalities of running a de-labelling clinic optimised for maximum patient volume. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Penicillin Allergy
- What is being tested?
- Single dose low-risk penicillin challenge
- Type of treatment
- Pill or oral medicine
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Penicillin allergy label
- Age ≥18
- Registered as a patient with University Hospital Southampton NHS Foundation Trust (with a UHS medical record)
- Able and willing to consent to penicillin de-labelling
Who cannot join
- Penicillin allergy previously confirmed via positive blood, skin, BAT or challenge testing
- PEN-FAST score >2 (indicating a moderate or high risk of a positive challenge)
- Anaphylaxis, angioedema, wheeze, shortness of breath or suspected hypotension linked to treatment with penicillin
- Received treatment in hospital for a reaction linked to penicillin (unless already an inpatient at onset)
- Itchy or urticarial rash within 1 hour of starting a new course of treatment with penicillin
- Severe cutaneous adverse reaction (SCAR) linked to penicillin exposure (e.g. SJS/TEN, DRESS), including symptoms suggestive of SCAR without a formal diagnosis (e.g. skin blistering or peeling, mucosal involvement)
Show all 14Show fewer
- History of other serious, non-immediate reactions linked to penicillin (e.g. haemolytic anaemia, transaminitis, nephritis)
- Currently pregnant or breastfeeding
- Poorly controlled asthma
- Severe COPD
- Severe or critical aortic stenosis
- Clinically unstable secondary to other organ failure
- Unwell or unstable on the day of proposed penicillin challenge (including acute febrile illness)
- Prescribed other antibiotics on the day of proposed challenge, unless taken as a long-term treatment/prophylaxis
Trial locations and contacts
No sites are listed yet.
About this study
Plenty of studies have now established the safety of low-risk penicillin allergy de-labelling, but few have addressed how to organise de-labelling at the clinic level. This study will test the real world practicalities of running a de-labelling clinic optimised for maximum patient volume. The sheer number of patients with a penicillin allergy label, in contrast to relatively few allergy centres, makes demonstrating that such an approach can work extremely important for future antimicrobial stewardship.
Read the detailed description
Participants with a penicillin allergy label will be invited to take part in the study, having been referred to the service by their hospital team. Based on the information provided with the referral, low-risk candidates will be identified.
Appointments will be offered to fill 36 clinic slots in total as part of the study.
On the day of their appointment, after providing written consent, participants will be asked some additional questions to confirm their eligibility for penicillin allergy de-labelling (and that the information provided in their referral form is accurate). Simple medical observations will also be taken (recording heart rate, blood pressure and oxygen saturation). Participants may be asked to return to the waiting area after these initial assessments.
Once a chair becomes available in the clinic, participants will be given a single dose of penicillin to take by mouth. They will then be observed for 1 hour. During this time they will be asked to complete a feedback form about their clinic experience.
Provided they do not experience a reaction they will then be discharged home, where they will be asked to complete a 3-day course of the same penicillin. They will be called during the next week to ensure that they completed the course and did not experience any delayed reactions. Their GP, and the person who referred to the service, will be informed of the outcome. Those that do not react will be able to receive penicillins in the future.
Participants should expect to be in the allergy department for up to 2 hours for their appointment.
The study does not need to be powered to make a specific statistical analysis possible; the intention is simply to demonstrate that a high-volume de-labelling service is viable. However, any one session may be affected by factors such as a high DNA rate, which would then mean that the clinic model is not tested at optimal capacity. To avoid this, and to make the overall results more compelling, the clinic will run on four occasions (with 36 patients in total).
- Conditions
- Penicillin Allergy
- Being tested
- Single dose low-risk penicillin challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose low-risk penicillin challengeDiagnostic test
Initial screening to establish low risk allergy status followed by a single dose challenge using a standard penicillin dose. All challenges will be oral, conducted in a hospital setting and will be followed by a 1 hour monitoring period.
What is being measured
The primary outcome is the main question the study is designed to answer.
How can low-risk penicillin allergy de-labelling be delivered with maximal efficiency in a resource limited setting?
Successful operation of the high-volume clinic model, assessed via:
- Number of patients reviewed and tested (if appropriate) within each allocated session
- Evidence of acceptability to patients from feedback forms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penicillin 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532448
- Sponsor's protocol ID
- RHM MED2073
- Acronym
- De-Label Me
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 5 Aug 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of High-volume, Low-risk Penicillin Allergy De-labelling to Maximise Efficiency in a Resource-limited Setting
- ClinicalTrials.gov ID
- NCT06532448
- Acronym / sponsor ID
- De-Label Me / RHM MED2073
- Conditions
- Penicillin Allergy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 1 Aug 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.
Plenty of studies have now established the safety of low-risk penicillin allergy de-labelling, but few have addressed how to organise de-labelling at the clinic level. This study will test the real world practicalities of running a de-labelling clinic optimised for maximum patient volume. The sheer number of patients with a penicillin allergy label, in contrast to relatively few allergy centres, makes demonstrating that such an approach can work extremely important for future antimicrobial stewardship.
Detailed description
Participants with a penicillin allergy label will be invited to take part in the study, having been referred to the service by their hospital team. Based on the information provided with the referral, low-risk candidates will be identified.
Appointments will be offered to fill 36 clinic slots in total as part of the study.
On the day of their appointment, after providing written consent, participants will be asked some additional questions to confirm their eligibility for penicillin allergy de-labelling (and that the information provided in their referral form is accurate). Simple medical observations will also be taken (recording heart rate, blood pressure and oxygen saturation). Participants may be asked to return to the waiting area after these initial assessments.
Once a chair becomes available in the clinic, participants will be given a single dose of penicillin to take by mouth. They will then be observed for 1 hour. During this time they will be asked to complete a feedback form about their clinic experience.
Provided they do not experience a reaction they will then be discharged home, where they will be asked to complete a 3-day course of the same penicillin. They will be called during the next week to ensure that they completed the course and did not experience any delayed reactions. Their GP, and the person who referred to the service, will be informed of the outcome. Those that do not react will be able to receive penicillins in the future.
Participants should expect to be in the allergy department for up to 2 hours for their appointment.
The study does not need to be powered to make a specific statistical analysis possible; the intention is simply to demonstrate that a high-volume de-labelling service is viable. However, any one session may be affected by factors such as a high DNA rate, which would then mean that the clinic model is not tested at optimal capacity. To avoid this, and to make the overall results more compelling, the clinic will run on four occasions (with 36 patients in total).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Penicillin allergy label
- Age ≥18
- Registered as a patient with University Hospital Southampton NHS Foundation Trust (with a UHS medical record)
- Able and willing to consent to penicillin de-labelling
Key exclusion criteria (14 listed)
- Penicillin allergy previously confirmed via positive blood, skin, BAT or challenge testing
- PEN-FAST score >2 (indicating a moderate or high risk of a positive challenge)
- Anaphylaxis, angioedema, wheeze, shortness of breath or suspected hypotension linked to treatment with penicillin
- Received treatment in hospital for a reaction linked to penicillin (unless already an inpatient at onset)
- Itchy or urticarial rash within 1 hour of starting a new course of treatment with penicillin
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 |
|---|---|---|
| Single dose low-risk penicillin challengeInitial screening to establish low risk allergy status followed by a single dose challenge using a standard penicillin dose. All challenges will be oral, conducted in a hospital setting and will be followed by a 1 hour monitoring period. | Diagnostic test | – |
Primary outcome
How can low-risk penicillin allergy de-labelling be delivered with maximal efficiency in a resource limited setting?
Time frame: 1 year
Successful operation of the high-volume clinic model, assessed via: 1. Number of patients reviewed and tested (if appropriate) within each allocated session 2. Evidence of acceptability to patients from feedback forms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 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.
Questions about this trial
What is this clinical trial studying?
A study testing Single dose low-risk penicillin challenge in people with Penicillin Allergy, run by University Hospital Southampton NHS Foundation Trust.
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 14 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 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mandy Ross (02381205213, mandy.ross@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
How can low-risk penicillin allergy de-labelling be delivered with maximal efficiency in a resource limited setting? (time frame: 1 year). 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 5 Aug 2024.