Prolonged versus single dose in penicillin oral challenge testing: protocols for a pilot and definitive randomised controlled trial (PROSPECTOR studies).

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Tác giả: Ana Copaescu, Suran Fernando, Lene Heise Garvey, Jack Godsell, Fiona James, Michael Lane, Amy Legg, Philip Li, Elise Mitri, Irvin Ng, Jonathan Grant Peter, Morgan Rose, Vito Sabato, Richard Sullivan, Jason Trubiano, Sara Vogrin

Ngôn ngữ: eng

Ký hiệu phân loại: 553.453 Tin

Thông tin xuất bản: England : BMJ open , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 577079

 INTRODUCTION: Penicillin allergy labels (PALs) are reported in 1 in 10 hospitalised patients globally and associated with inferior patient, hospital and microbiological outcomes
  however, the majority are incorrect and should be removed. Direct oral penicillin challenge has been demonstrated to be a safe and effective method for the removal of PALs. However, the question of whether a single dose is sufficient to ascertain true allergy status remains unanswered, with some studies suggesting that extended challenges of 3 or more days are superior for the exclusion of delayed immune reactions. The aim of the PROSPECTOR studies was to determine the feasibility (PROSPECTOR-1) of a definitive trial (PROSPECTOR-2) to evaluate the safety and effectiveness of prolonged oral challenge (ie, 5 days) versus single-dose oral challenge in patients with a delayed or unknown penicillin allergy phenotype (PROSPECTOR-2). METHODS AND ANALYSIS: A pair of double-blind two-arm parallel placebo-controlled trials will be undertaken ETHICS AND DISSEMINATION: These studies were reviewed and approved by the Austin Health Human Research Ethics Committee (PROSPECTOR-1: HREC/99740/Austin-2023 and PROSPECTOR-2: HREC/109785/Austin-2024). The results will be published in peer-reviewed journals and presented at relevant conferences. TRIAL REGISTRATION NUMBER: PROSPECTOR-1: ACTRN12623001242617 and PROSPECTOR-2: ACTRN12624001107516.
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