Status:
COMPLETED
Allergy Antibiotics And Microbial Resistance
Lead Sponsor:
University of Leeds
Collaborating Sponsors:
University of Oxford
Conditions:
Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
ALBAMA study is designed to find out if the effects of Penicillin allergy assessment pathway (PAAP) intervention is on penicillin prescribing
Detailed Description
* Antibiotics are important medicines for fighting infections caused by bacteria. Their widespread use has caused a worrying rise in antibiotic resistant bacteria, which are bacteria that are harder t...
Eligibility Criteria
Inclusion
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged 18 years or above
- Current penicillin allergy (or sensitivity) record of any kind in their electronic health record
- Receipt of either: penicillin, cephalosporin, tetracycline, quinolone or macrolide class antibiotic or fosfomycin, nitrofurantoin, trimethoprim, clindamycin in the previous 12 months
- N.B.1 Patients who have been formally tested for penicillin allergy in the past and been found not to be penicillin allergic but still have a medical record indicating a penicillin allergy, are eligible for the trial.
Exclusion
- Life expectancy estimated \<1 year by GP
- Unable to attend immunology clinic
- Unsuitable for entry into testing pathway because:
- Allergy history consistent with anaphylaxis to penicillin
- 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
- Has been formally tested for penicillin allergy in the past and been found to be penicillin allergic
- History of brittle/severe asthma or has had a course of steroids in the past 3 months for asthma or unstable coronary artery disease, or dermographism or other severe/poorly controlled skin conditions
- Considered unsuitable for trial participation by the GP e.g. because of chaotic lifestyle
- Pregnant
- Breastfeeding mothers
- Taking beta blocker medication, and unable to temporarily withhold these on the day of penicillin allergy testing
- Currently taking (or recently taken) systemic steroids and unable to stop these for 10 days pretesting.
- Currently taking antihistamines and unable to temporarily withhold these for 72 hours pre-testing
- GPs may also want to exclude vulnerable patients who are deemed to be unsuitable to participate for other reasons such as, but not limited to, terminal illness, reliability, mental illness, learning difficulties, anxiety, and other family circumstances.
- N.B.1 Patients that are currently taking medicines with antihistamine properties that cannot be temporarily withheld, or patients with isolated dermographism, may still be eligible to participate but will need to be discussed with the research team prior to consent.
- N.B.2 Pregnancy and breastfeeding exclusion criteria are only applicable at screening (due to potential risks of PAT); these patients would not need to be withdrawn if in follow up.
Key Trial Info
Start Date :
July 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
823 Patients enrolled
Trial Details
Trial ID
NCT04108637
Start Date
July 4 2019
End Date
April 30 2024
Last Update
June 5 2024
Active Locations (1)
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1
NIHR CRN: Yorkshire and Humber
York, United Kingdom, S10 2SB