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

Abstract

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.

Metadata

Authors/Creators:

Armitage, K.F. https://orcid.org/0000-0001-5438-5290
Porter, C.E.
Ahmed, S.
Cook, J.
Boards, J.
Bongard, E. https://orcid.org/0000-0001-5957-6280
Butler, C.C. https://orcid.org/0000-0002-0102-3453
Corfield, K.
Davoudianfar, M.
Galal, U.
Howard, P. https://orcid.org/0000-0002-5096-0240
Mujica-Mota, R. https://orcid.org/0000-0002-7430-2744
Saman, R. https://orcid.org/0000-0002-0733-9344
Santillo, M. https://orcid.org/0000-0001-6345-7612
Savic, S. https://orcid.org/0000-0001-7910-0554
Shinkins, B.
Tonkin-Crine, S. https://orcid.org/0000-0003-4470-1151
Wanat, M. https://orcid.org/0000-0002-0163-1547
West, R.M. https://orcid.org/0000-0001-7305-3654
Yu, L.M.
Pavitt, S. https://orcid.org/0000-0001-7447-440X
Sandoe, J.A.T. https://orcid.org/0000-0003-0193-8677

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Keywords:

Humans; Hypersensitivity; Drug Hypersensitivity; Penicillins; Anti-Bacterial Agents; Pilot Projects; Drug Resistance, Bacterial; Adult; State Medicine; Alabama; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Pragmatic Clinical Trials as Topic

Dates: