Feasibility of Direct Oral Challenges in Private Practice Setting for the Evaluation of Mild Delayed Reactions to Beta-lactams in Children

What this Trial Is About

This research aims to evaluate the feasibility of performing direct oral challenges (DOC) in private medical practices for children suspected of having benign delayed allergy to beta-lactams (BL). Many children are labeled as allergic to BL antibiotics, but true allergy is confirmed in only 5-10% of cases. Identifying non-allergic children quickly can prevent unnecessary use of alternative antibiotics, which may be less effective and carry other risks. The study focuses on mild delayed reactions in children and seeks to inform recommendations for DOC use in primary care settings. Children who have been labeled with suspected BL allergy and require a direct oral challenge will participate in this observational study. The DOC is performed in private medical practices, followed by a consultation within 7 to 14 days. The study observes reactions to antibiotics such as amoxicillin, amoxicillin-clavulanate, cefpodoxime, or cefixime. It aims to compare the nature, timing, duration, and extent of reactions in positive and negative tests. Participants will be monitored through follow-up visits about two weeks after the oral challenge to assess any allergic reactions and their characteristics. Researchers will collect data on the feasibility of conducting DOCs in private settings and analyze reactions to confirm or rule out true allergy. The primary outcome is the feasibility of the DOC procedure within 14 days. Safety and reaction details will also be recorded during this period. The study is expected to last until June 2027.

Direct Oral Challenges in Private Practice Setting to Delabeling Children With Beta-lactam Allergy