1. Randomized Multicenter Trial for the Validation of an Easy-to-Administer Algorithm to Define Penicillin Allergy Status in Sexually Transmitted Infection Clinic Outpatients.
- Author
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Lillis RA, Barbee LA, McNeil CJ, Newman L, Fortenberry JD, Alvarez-Arango S, and Zenilman JM
- Subjects
- Humans, Male, Adult, Female, Middle Aged, Skin Tests methods, Anti-Bacterial Agents administration & dosage, Anti-Bacterial Agents adverse effects, Anti-Bacterial Agents therapeutic use, Sexually Transmitted Diseases diagnosis, Sexually Transmitted Diseases drug therapy, Young Adult, Outpatients, Surveys and Questionnaires, Drug Hypersensitivity diagnosis, Algorithms, Penicillins adverse effects, Penicillins administration & dosage
- Abstract
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: Randomized controlled trial 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., Conclusions: 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. Clinical Trials Registration. Clinicaltrials.gov (NCT04620746)., Competing Interests: Potential conflicts of interest. L. A. B. reports research funding support from NIH, Nabriva, Hologic, and SpeeDx, and participation on a Data and Safety Monitoring Board for an NIH-funded study on the Bexsero vaccine (looking at mucosal immunity). C. J. M. reports receiving research funding from BARDA/GSK, the Centers for Disease Control and Prevention, GlaxoSmithKline, Cepheid, Gilead, Hologic, and the National Association of County and CityHealth Officials and consulting honoraria from the Infectious Diseases Society of America, Contraceptive Technologies, Core Concepts in Health, and AHEC (Area Health Education Centers); and participation on a Data Safety Monitoring Board or Advisory Board for the NIH (unpaid) and Advisory Board for Talis Biomedical (payment to their institution); and receipt of study product provided to their institution from Lupin. J. M. Z. reports compensation for service on Data Safety Monitoring Committees for Pfizer. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2024
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