Background Approximately 15% of patients in sexually transmitted infection (STI) clinics report penicillin allergies, complicating treatment for syphilis and gonorrhea. Nonetheless, > 90% do not have a penicillin allergy when evaluated. We developed and validated an algorithm to define which patients reporting penicillin allergy can be safely treated at STI clinics with these drugs. Methods RCT to assess feasibility and safety of penicillin allergy evaluations in STI clinics. Participants with reported penicillin allergy answered an expert-developed questionnaire to stratify risk. Low-risk participants underwent penicillin skin testing (PST) followed by amoxicillin 250 mg challenge or a graded oral challenge (GOC)—amoxicillin 25 mg followed by 250 mg. Reactions were recorded, and participant/provider surveys were conducted. Results Of 284 participants, 72 (25.3%) were deemed high-risk and were excluded. Of 206 low-risk participants, 102 (49.5%) underwent PST without reactions and 3 (3%) had mild reactions during the oral challenge. Of 104 (50.5%) participants in the GOC, 95 (91.3%) completed challenges without reaction, 4 (4.2%) had mild symptoms after 25 mg and 4 (4.2%) after 250 mg doses. Overall, 195 participants (94.7%) successfully completed the study and 11 (5.3%) experienced mild symptoms. Of 14 providers, 12 (85.7%) completed surveys and 11 (93%) agreed on the safety/effectiveness of penicillin allergy assessment in STI clinics. Conclusion An easy-to-administer risk assessment questionnaire can safely identify patients for penicillin allergy evaluation in STI clinics by PST or GOC, with GOC showing operational feasibility. Using this approach, 67% of participants with reported penicillin allergy could safely receive first-line treatments for gonorrhea or syphilis.

中文翻译：

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随机多中心试验，用于验证一种易于管理的算法，用于定义性传播感染诊所门诊患者的青霉素过敏状态

背景 性传播感染 (STI) 诊所中大约 15% 的患者报告青霉素过敏，这使得梅毒和淋病的治疗变得复杂化。尽管如此，>评估时，90% 的人没有青霉素过敏。我们开发并验证了一种算法，以确定哪些报告青霉素过敏的患者可以在性传播感染诊所用这些药物安全地接受治疗。方法通过随机对照试验（RCT）评估性传播感染诊所中青霉素过敏评估的可行性和安全性。报告青霉素过敏的参与者回答了专家制定的问卷以对风险进行分层。低风险参与者接受青霉素皮试 (PST)，然后接受阿莫西林 250 毫克挑战或分级口服挑战 (GOC)——阿莫西林 25 毫克，然后 250 毫克。记录反应，并进行参与者/提供者调查。结果 在 284 名参与者中，72 名 (25.3%) 被视为高风险并被排除在外。在 206 名低风险参与者中，102 名 (49.5%) 接受了 PST，没有出现反应，3 名 (3%) 在口服挑战期间出现轻微反应。在 GOC 的 104 名参与者 (50.5%) 中，95 名 (91.3%) 名参与者在没有反应的情况下完成了挑战，4 名 (4.2%) 名在 25 毫克剂量后出现轻微症状，4 名 (4.2%) 名在 250 毫克剂量后出现轻微症状。总体而言，195 名参与者 (94.7%) 成功完成了研究，其中 11 名参与者 (5.3%) 出现了轻微症状。在 14 家提供者中，12 家 (85.7%) 完成了调查，11 家 (93%) 同意性传播感染诊所中青霉素过敏评估的安全性/有效性。结论 易于管理的风险评估问卷可以安全地识别患者，通过 PST 或 GOC 在 STI 诊所进行青霉素过敏评估，GOC 显示出操作可行性。使用这种方法，67% 报告青霉素过敏的参与者可以安全地接受淋病或梅毒的一线治疗。