Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.
Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds, Leeds, West Yorkshire, UK.
BMJ Open. 2023 Sep 4;13(9):e072253. doi: 10.1136/bmjopen-2023-072253.
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.
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.
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.
ISRCTN20579216.
不正确的青霉素过敏记录被认为是安全治疗感染的一个重要障碍，据估计，在英格兰有 270 万人受到影响。青霉素过敏记录与更糟糕的健康结果和抗菌素耐药性有关。过敏抗生素和微生物耐药性（ALABAMA）试验旨在确定一个干预方案是否安全有效，该方案围绕初级保健中启动的青霉素过敏评估途径（PAAP），是否能改善患者的健康结果和抗生素处方。
ALABAMA 试验是一项多中心、平行臂、开放标签、随机实用试验，嵌套有一个试点研究。年龄在 18 岁及以上，有青霉素过敏记录且在过去 24 个月内接受过抗生素治疗的成年人将有资格参加。将从英国参与的国民保健服务全科医生中招募 1592 至 2090 名参与者。参与者将以 1:1 的分配比例随机分配到常规护理或干预组，以进行先发制人的 PAAP。主要结局指标是指数处方后 28 天内治疗反应失败的百分比。预计 2090 名和 1592 名参与者将分别提供 90%和 80%的效力，以在 1 年内检测到组间治疗反应失败的主要结局的临床重要绝对差异 7.9%。该试验包括混合方法的过程评估和成本效益评估。
该试验已获得伦敦桥研究伦理委员会的批准（参考号：19/LO/0176）。它将根据《赫尔辛基宣言》按照良好临床实践指南进行。将获得所有参与研究的受试者的知情同意。主要试验结果将提交给国际同行评议期刊发表。
ISRCTN20579216。
