AllergyPADLESNCT03607734
Penicillin Allergy De-Labelling in Elective Surgical Patients (PADLES)
A study testing Amoxicillin in people with Allergy, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Penicillin antibiotics are safe and inexpensive, and target selected bacteria rather than killing a broad range. Unfortunately, around 10% of the population are labelled as 'penicillin allergic'. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy
- What is being tested?
- Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2017to 2 Oct 2017
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Allergic history is historic (more than 10 years ago) and suggestive of a non-immediate reaction or side effect
- Requires penicillin as first-line treatment for their planned surgery
- >18 years
- Willing and able to give consent
Who cannot join
- Not willing to participate
- History suggestive of immediate type reaction (anaphylaxis)
- History of toxic epidermal necrolysis or Stevens Johnson syndrome
- Pregnant, planning to become pregnant during study, or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Penicillin Allergy De-Labelling in Elective Surgical Patients - A Study to Determine the Safety, Efficacy and Feasibility of Abbreviated Allergy Testing
Penicillin antibiotics are safe and inexpensive, and target selected bacteria rather than killing a broad range. Unfortunately, around 10% of the population are labelled as 'penicillin allergic'. This is often based on side effects such as rash and diarrhoea, and 90-95% of people with the label are not actually allergic to the drug.
The label leads to the use of alternative antibiotics, which tend to more toxic, and less specific about which bacteria they kill; this increases the risk of infections with so-called 'super-bugs', compared to patients without the label. People with the label also have an increased length of hospital stay and rates of readmission. These are significant problems for individuals, as well as wider society. Where the diagnosis is in doubt, the gold standard test for allergy is an oral challenge. Patients undergo skin +/- blood tests prior to a challenge, as these can help make the diagnosis. This combined pathway is expensive and time consuming, so testing cannot be offered routinely to all patients. However in patients with 'historic' reactions (many years previously), skin and blood tests become much less useful; in one study, 100% of patients who skin tested positive for amoxycillin allergy, tested negative 5 years later. Patients with historic reactions can therefore proceed directly to an oral challenge without prior skin or blood testing, since these offer little help in making the diagnosis. This streamlines the pathway, making it quick, non-invasive and cheap. Already established practice in several centres in Europe and beyond, this abbreviated pathway is offered on an ad-hoc basis in some centres in the UK.
The aim is to demonstrate that this pathway offers a safe and effective way to perform large-scale delabelling of elective surgical patients, who might not otherwise meet NICE criteria for testing.
- Conditions
- Allergy
- Being tested
- Amoxicillin
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
A graded oral challenge test, using amoxicillin in syrup form, will be administered as follows:
- 50mg amoxicillin (10% total dose)
- 250mg amoxicillin (50% total dose)
- 200mg amoxicillin (remainder needed to complete a 500mg full dose) A 20 minute interval will separate each dose given, and participants will be observed throughout the test. They will be required to stay for one hour after the final dose has been administered. Fully trained staff and all equipment for emergency resuscitation will be immediately available.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Interventional Treatment | Other | A graded oral challenge test, using amoxicillin in syrup form, will be administered as follows:
* 50mg amoxicillin (10% total dose)
* 250mg amoxicillin (50% total dose)
* 200mg amoxicillin (remainder needed to complete a 500mg full dose) A 20 minute interval will separate each dose given, and participants will be observed throughout the test. They will be required to stay for one hour after the final dose has been administered. Fully trained staff and all equipment for emergency resuscitation will be immediately available. Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of the study questionnaire by participants
Online questionnaire about previously diagnosed allergies to be completed by study participants
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start24 Apr 2017
- Primary completion2 Oct 2017
- Study completion2 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607734
- Sponsor's protocol ID
- AN17/92982
- Acronym
- PADLES
- Status last verified
- Jul 2018
- First submitted
- 27 Jun 2018
- Last updated
- 31 Jul 2018
- Results posted
- 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 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penicillin Allergy De-Labelling in Elective Surgical Patients - A Study to Determine the Safety, Efficacy and Feasibility of Abbreviated Allergy Testing
- ClinicalTrials.gov ID
- NCT03607734
- Acronym / sponsor ID
- PADLES / AN17/92982
- Conditions
- Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 2 Oct 2017 (actual)
- First posted
- 31 Jul 2018 (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.
Penicillin antibiotics are safe and inexpensive, and target selected bacteria rather than killing a broad range. Unfortunately, around 10% of the population are labelled as 'penicillin allergic'. This is often based on side effects such as rash and diarrhoea, and 90-95% of people with the label are not actually allergic to the drug.
The label leads to the use of alternative antibiotics, which tend to more toxic, and less specific about which bacteria they kill; this increases the risk of infections with so-called 'super-bugs', compared to patients without the label. People with the label also have an increased length of hospital stay and rates of readmission. These are significant problems for individuals, as well as wider society. Where the diagnosis is in doubt, the gold standard test for allergy is an oral challenge. Patients undergo skin +/- blood tests prior to a challenge, as these can help make the diagnosis. This combined pathway is expensive and time consuming, so testing cannot be offered routinely to all patients. However in patients with 'historic' reactions (many years previously), skin and blood tests become much less useful; in one study, 100% of patients who skin tested positive for amoxycillin allergy, tested negative 5 years later. Patients with historic reactions can therefore proceed directly to an oral challenge without prior skin or blood testing, since these offer little help in making the diagnosis. This streamlines the pathway, making it quick, non-invasive and cheap. Already established practice in several centres in Europe and beyond, this abbreviated pathway is offered on an ad-hoc basis in some centres in the UK.
The aim is to demonstrate that this pathway offers a safe and effective way to perform large-scale delabelling of elective surgical patients, who might not otherwise meet NICE criteria for testing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Interventional Treatment | Other | Drug: AmoxicillinA graded oral challenge test, using amoxicillin in syrup form, will be administered as follows: * 50mg amoxicillin (10% total dose) * 250mg amoxicillin (50% total dose) * 200mg amoxicillin (remainder needed to complete a 500mg full dose) A 20 minute interval will separate each dose given, and participants will be observed throughout the test. They will be required to stay for one hour after the final dose has been administered. Fully trained staff and all equipment for emergency resuscitation will be immediately available. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Allergic history is historic (more than 10 years ago) and suggestive of a non-immediate reaction or side effect
- Requires penicillin as first-line treatment for their planned surgery
- >18 years
- Willing and able to give consent
Key exclusion criteria (4 listed)
- Not willing to participate
- History suggestive of immediate type reaction (anaphylaxis)
- History of toxic epidermal necrolysis or Stevens Johnson syndrome
- Pregnant, planning to become pregnant during study, or breastfeeding
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 |
|---|---|---|
| AmoxicillinA graded oral challenge test, using amoxicillin in syrup form, will be administered as follows: * 50mg amoxicillin (10% total dose) * 250mg amoxicillin (50% total dose) * 200mg amoxicillin (remainder needed to complete a 500mg full dose) A 20 minute interval will separate each dose given, and participants will be observed throughout the test. They will be required to stay for one hour after the final dose has been administered. Fully trained staff and all equipment for emergency resuscitation will be immediately available. | Drug | Group 1 - Interventional Treatment |
Primary outcome
Completion of the study questionnaire by participants
Time frame: 1 day
Online questionnaire about previously diagnosed allergies to be completed by study participants
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 31 Jul 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.
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?
A study testing Amoxicillin in people with Allergy, run by The Leeds Teaching Hospitals NHS Trust 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 4 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 31 Jul 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 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?
Completion of the study questionnaire by participants (time frame: 1 day). 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 31 Jul 2018.