ALlergy AntiBiotics And Microbial resistAnce (ALABAMA)
Research type
Research Study
Full title
Penicillin allergy status and its effect on antimicrobial prescribing, patient outcomes, and antimicrobial resistance.
IRAS ID
252976
Contact name
Jonathan Sandoe
Contact email
Sponsor organisation
University of Leeds
ISRCTN Number
ISRCTN20579216
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 1 months, 28 days
Research summary
Penicillin’s are the most commonly prescribed antibiotics for many common infections. Patients with a penicillin allergy are not usually prescribed penicillins and receive alternative treatments which may be less effective and have additional long-term health risks.
ALABAMA protocol focuses on the large discrepancy between reported and true penicillin allergy rates; a penicillin allergy assessment pathway(PAAP)for patients who are likely to receive antibiotics, could improve patient outcomes, and reduce the risk of antibiotic resistance as well as NHS costs. Recruitment will be via GP practices, aiming to recruit 96 patients for feasibility and 1994 for main trial. Eligible patients with a record of penicillin allergy will be invited to participate. Respondents will be consented and randomised to either usual care or the PAAP arm. Patients who are randomised to the PAAP arm, will be asked to undergo penicillin allergy testing, involving: penicillin allergy history; 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 patient's electronic health records are updated. Antibiotic prescriptions will be monitored as well as other health outcomes.
Patients will be followed up for 4 months for the feasibility study and, following a stop go, 12 months in the main trial. When patients are prescribed an antibiotic, an alert will be sent to the trial team who will follow up the participant for 28 days after each event. At the end of the follow up period their health records in primary and secondary care will be reviewed to ensure all antibiotic events and outcomes are captured.
GPs will be participants within the process evaluation of ALABAMA. GPs will be invited to complete questionnaires to understand their knowledge and beliefs about penicillin allergy testing and referring patients for testing. A subset of GPs will be invited to take part in an interview at the end of the trial to discuss their experiences.REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/0176
Date of REC Opinion
29 Jan 2019
REC opinion
Favourable Opinion