Penicillin allergy status and its effect on antibiotic prescribing, patient outcomes and antimicrobial resistance (ALABAMA): protocol for a multicentre, parallel-arm, open-label, randomised pragmatic trial
Sarah Tonkin-Crine,
Sinisa Savic,
Robert M West,
Ly-Mee Yu,
Sue Pavitt,
Ushma Galal,
Christopher C Butler,
Marta Wanat,
Johanna Cook,
Bethany Shinkins,
Mina Davoudianfar,
Emily Bongard,
Philip Howard,
Marta Santillo,
Jenny Boards,
Jonathan A T Sandoe,
Ruben Mujica-Mota,
Razan Saman,
Kelsey Fiona Armitage,
Catherine E Porter,
Shadia Ahmed,
Kate Corfield
Affiliations
Sarah Tonkin-Crine
Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK
Sinisa Savic
Clinical Immunology and Allergy, University of Leeds Leeds Institute of Medical Research at St James`s, Leeds, UK
Robert M West
Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
Ly-Mee Yu
Oxford Primary Care Clinical Trials Unit, Nuffield Department of Primary care Health Sciences, University of Oxford, Oxford, UK
Sue Pavitt
Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds, Leeds, West Yorkshire, UK
Ushma Galal
Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK
Christopher C Butler
Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK
Marta Wanat
Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK
Johanna Cook
Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK
Bethany Shinkins
Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
Mina Davoudianfar
Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK
Emily Bongard
Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK
Philip Howard
School of Healthcare, University of Leeds, Leeds, UK
Marta Santillo
Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK
Jenny Boards
Leeds Teaching Hospitals NHS Trust, Leeds, Leeds, UK
Jonathan A T Sandoe
Leeds Institute of Medical Research, School of Medicine, University of Leeds, Leeds, UK
Ruben Mujica-Mota
Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
Razan Saman
Leeds Teaching Hospitals NHS Trust, Leeds, Leeds, UK
Kelsey Fiona Armitage
Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK
Catherine E Porter
Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds, Leeds, West Yorkshire, UK
Shadia Ahmed
Leeds Teaching Hospitals NHS Trust, Leeds, Leeds, UK
Kate Corfield
Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK
Introduction Incorrect penicillin allergy records are recognised as an important barrier to the safe treatment of infection and affect an estimated 2.7 million people in England. Penicillin allergy records are associated with worse health outcome and antimicrobial resistance. The ALlergy AntiBiotics And Microbial resistAnce (ALABAMA) trial aims to determine if an intervention package, centred around a penicillin allergy assessment pathway (PAAP) initiated in primary care, is safe and effective in improving patient health outcomes and antibiotic prescribing.Methods and analysis The ALABAMA trial is a multicentre, parallel-arm, open-label, randomised pragmatic trial with a nested pilot study. Adults (≥18 years) with a penicillin allergy record and who have received antibiotics in the previous 24 months will be eligible for participation. Between 1592 and 2090 participants will be recruited from participating National Health Service general practices in England. Participants will be randomised to either usual care or intervention to undergo a pre-emptive PAAP using a 1:1 allocation ratio. The primary outcome measure is the percentage of treatment response failures within 28 days of an index prescription. 2090 and 1592 participants are estimated to provide 90% and 80% power, respectively, to detect a clinically important absolute difference of 7.9% in primary outcome at 1 year between groups. The trial includes a mixed-methods process evaluation and cost-effectiveness evaluation.Ethics and dissemination This trial has been approved by London Bridge Research Ethics Committee (ref: 19/LO/0176). It will be conducted in compliance with Good Clinical Practice guidelines according to the Declaration of Helsinki. Informed consent will be obtained from all subjects involved in the study. The primary trial results will be submitted for publication to an international, peer-reviewed journal.Trial registration ISRCTN20579216.
