Penicillin allergy Injury, Occupational Diseases, Poisoning
Conditions
Interventions
During their call with the research team, participants will be asked if they have taken any antibiotics in the previous two weeks, if they have, the randomisation/baseline call will be postponed until
skin testing and/or oral challenge test. Patients will receive their allergy test result by a letter and/or email. Practices will be informed of the results and will be asked to ensure that the patien
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 22/03/2024: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. Penicillin allergy (or sensitivity) record of any kind in their electronic health record 4. Prescribed systemic antibiotics, either: penicillin, cephalosporin, tetracycline, quinolone, macrolide, glycopeptide, aminoglycoside, oxazolidinone, monobactam or carbapenem class antibiotic or fosfomycin, nitrofurantoin, trimethoprim, clindamycin, rifampicin, colistin, metronidazole in the previous 24 months NB Patients with a penicillin allergy record and a recent penicillin prescription would still be eligible because their allergy status will need assessment and records correcting if necessary. _____ Previous inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. Penicillin allergy (or sensitivity) record of any kind in their electronic health record 4. Receipt of either: penicillin, cephalosporin, tetracycline, quinolone or macrolide class antimicrobial or fosfomycin, nitrofurantoin, trimethoprim, clindamycin in the previous 12 months NB Patients with a penicillin allergy record and a recent penicillin prescription would still be eligible because their allergy status will need assessment and records correcting if necessary.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 22/03/2024: 1. Life expectancy estimated < 1 year by GP 2. Unable to attend hospital clinic where allergy testing takes place 3. Unsuitable for entry into testing pathway because: 3.1. Allergy history consistent with anaphylaxis to penicillin 3.2. History of toxic epidermal necrolysis, Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS) or any severe rash which blistered or needed hospital treatment, and acute generalised exanthematous pustulosis precipitated by a penicillin 3.3. Has been formally tested for penicillin allergy in the past and been found to be penicillin allergic 3.4. History of brittle asthma (had a course of steroids in the past 3 months) or unstable coronary artery disease, or dermographism or other severe/poorly controlled skin conditions 3.5. Considered unsuitable for trial participation by the GP e.g. because of chaotic lifestyle 4. Pregnant 5. Breastfeeding mothers 6, Currently taking beta blocker medication and unable to temporarily withhold these on the day of penicillin allergy testing 7. Currently taking (or recently taken) systemic steroids and unable to top these for 10 days pre-testing 8. Currently taking antihistamines and unable to temporarily withhold these for 72 hours pre-testing _____ Previous exclusion criteria: 1. Life expectancy estimated < 1 year by GP 2. Unable to attend immunology clinic 3. Unsuitable for entry into testing pathway because: 3.1. Allergy history consistent with anaphylaxis to penicillin 3.2. History of toxic epidermal necrolysis, Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS) or any severe rash which blistered or needed hospital treatment, and acute generalised exanthematous pustulosis precipitated by a penicillin 3.3. Previous specialist investigation for penicillin allergy 3.4. History of brittle asthma (had a course of steroids in the past 3 months) or unstable coronary artery disease, or dermographism or other severe/poorly controlled skin conditions 3.5. Considered unsuitable for trial participation by the GP e.g. because of chaotic lifestyle 4. Pregnant/planning to become pregnant during the course of the study 5. Breastfeeding mothers 6. Currently receiving or due to start immunosuppressive medication 7. Currently taking (or recently taken, within 10 days) steroids 8. Currently taking antihistamines and unable to stop these for 4 days pre-testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 22/03/2024: The proportion of participants who receive prescriptions for a penicillin when attending for predefined conditions where a penicillin is the first-line recommended antibiotic (APPENDIX G) up to 12 months post randomisation (SystmOne report/primary care notes review/secondary care notes review/report, patient follow-up calls). _____ Previous primary outcome measure: Treatment “response failure” defined as: re-presentation with worsening or non-resolving symptoms following treatment with an antibiotic up to 28 days after initial antibiotic prescription (including re-prescription of antibiotic within 28 days of an index prescription) for predefined conditions (TPP/notes review), over the year subsequent to randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/03/2024: 1. Treatment “response failure” defined as: Re-presentation with worsening or non-resolving or new symptoms following treatment with an antibiotic up to 28 days after initial antibiotic prescription (including re-prescription of antibiotic within 28 days of an index prescription) for predefined infections (SystmOne report, diary), up to 12 months post randomisation. 2. Duration of symptoms rated ‘moderately bad’ or worse by patients after antibiotic treatment (diary/research nurse phone calls) 3. Total antibiotic use (measured by number of days treatment, number of prescriptions and Defined Daily Dose (DDD).), and analysed by penicillin/non-penicillin and antibiotic class (SystmOne report/primary care notes review/secondary care notes review). 4. Number of hospital admissions and length of hospital stays (Hospital Episode Statistic (HES)/secondary care notes review) 5. Mortality rates between intervention arms (primary care notes review/secondary care notes HES-ONS/SystmOne Report) 6. Number of patients with MRSA infection/new colonisation (primary care notes review/secondary care notes review/SystmOne report) 7. Number of patients with Clostridioides difficile infection (SystmOne report/primary care notes review/secondary care notes review) 8. Healthcare professional and patient interviews to explore patient and clinician views and experiences of penicillin allergy testing, test results and future antibiotic use. 9. Healthcare professional and patient interviews to explore patient and clinician experiences of trial procedures. 10. Change in self-reported behaviour and influences on behaviour by patients. 11. Self-reported health/QoL outcome: EQ-5D-5L™ will be used as a standardised instrument for measuring health outcome at baseline and 1 year. For those that receive antibiotics for pre-defined infections, EQ5D-5L will be collected on day 2-4 and day 28-30 after antibiotic treatment. NHS health resource use wil | — |
Countries
United Kingdom
Contacts
Public ContactKelsey Armitage
Outcome results
None listed