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

BMJ Open. 2023 Sep 4;13(9):e072253. doi: 10.1136/bmjopen-2023-072253.


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.

Keywords: clinical trial; immunology; infectious diseases; primary care.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

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


  • Anti-Bacterial Agents
  • Penicillins

Associated data

  • ISRCTN/ISRCTN20579216