Study: Antibiotic Allergy Delabeling Is Feasible and Safe With Few Adverse Events

Low-risk β-lactam antibiotic allergy labels (AALs) were successfully evaluated and delabeled by anesthesiologists in the preoperative clinic through a smartphone application, as demonstrated by clinical data published in JAMA Surgery. This application utilized a decision support algorithm that was adapted from a validated antibiotic allergy assessment tool, wrote the authors.¹

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Prior research published in the British Journal of Clinical Pharmacology explained that AALs are reported by approximately 20% of patients who are hospitalized; however, 85% are negative when evaluated via formal allergy testing. Additionally, those who are hospitalized with an AAL often have inferior patient outcomes, increased colonization with multidrug-resistant organisms, and often receive inappropriate antimicrobials.²

Expanding on this, AALs impact not only patient health but also perioperative outcomes, wrote the JAMA Surgery study authors. They hypothesized that AAL delabeling may improve antibiotic prescribing and infection-related outcomes perioperatively. In their study, they assessed the feasibility and safety of antibiotic allergy assessment and delabeling in preoperative assessment clinics led by anesthesiologists, expanding delabeling efforts outside of specialists’ offices and allergy clinics.^1,2

For this randomized, multicenter phase 2 clinical trial conducted between December 14, 2020, and October 31, 2023, the investigators assessed feasibility and safety outcomes of patients at outpatient preoperative anesthesiologist-led clinics at 3 tertiary hospitals. Patients enrolled were adults who were at least 18 years of age with a reported β-lactam AAL and likely to require intravenous (IV) antibiotic therapy for perioperative prophylaxis. Patients were randomly assigned to receive enhanced allergy assessment by anesthesiologists via a smartphone application that used a decision support algorithm adapted from a validated antibiotic allergy assessment tool. Risk scores were guided by antibiotic allergy testing, which consisted of a direct oral challenge if patients were considered low-risk or skin testing followed by an oral challenge for those who were medium- to high-risk.¹

The 2 primary feasibility end points were the portion of patients who were assigned to intervention who received intervention per protocol and the proportion of patients consenting to participate out of those who were eligible. Additionally, the primary safety end point was the proportion of the intervention group who experienced an adverse event (AE) related to antibiotics within 90 days postsurgery.¹

For this trial, a total of 150 patients (median age: 67 years; range: 28–89 years) were enrolled. Among this population, 74 were randomly assigned to receive the study intervention, and 76 were controls. Most of the patients were female (n = 78; 52%). For feasibility of recruitment, 150 of 511 patients (29.4%; 95% CI, 25.4%–33.5%) with eligible AALs were enrolled.¹

Further, for feasibility of intervention delivery, 47 of 74 patients (63.5%; 95% CI, 51.5%–74.4%) randomly assigned to intervention had allergy testing, and about 93% of patients (n = 28 of 30) assessed as low-risk and 43% (n = 19 of 44) assessed as moderate- or high-risk proceeded to allergy testing. The data demonstrated that antibiotic-related AEs were reported in 4 of 74 intervention patients (5.4%, 95% CI, 1.5%–13.3%) with only 1 event believed to be immune-mediated (benign rash) without a delay to surgery. There was also less restricted antibiotic use in the intervention group (n = 6; 10.7%) when compared with the control group (n = 10; 17.9%).¹

The absence of severe AEs after the intervention provides reassurance that antibiotic allergy delabeling can be achieved as part of a preoperative workup without delaying procedures, potentially improving the choice of preferred β-lactam prophylaxis, wrote the study authors. Based on these findings, the authors concluded that the low-risk β-lactam allergy delabeling supported by a smartphone application is feasible and safe.¹

REFERENCES

1. De Luca JF, Vogrin S, Holmes NE, et al. Perioperative Penicillin and Cephalosporin Antibiotic Allergy Assessment and Testing: The PREPARE Pilot Randomized Clinical Trial. JAMA Surg. Published online March 26, 2025. doi:10.1001/jamasurg.2025.0279

2. Moran R, Devchand M, Smibert O, Trubiano JA. Antibiotic allergy labels in hospitalized and critically ill adults: A review of current impacts of inaccurate labelling. Br J Clin Pharmacol. 2019;85(3):492-500. doi:10.1111/bcp.13830