Allergy, antibiotics and microbial resistance
- Conditions
- Penicillin allergyInjury, Occupational Diseases, Poisoning
- Registration Number
- ISRCTN20579216
- Lead Sponsor
- niversity of Leeds
- Brief Summary
2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36691248/ results of mixed-methods process evaluation embedded within the ALABAMA trial (added 25/01/2023) 2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-072253 (added 05/09/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 823
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method