The PROSPECTOR Studies

KEY INFORMATION

The PROlonged versus Single dose in PEnicillin oral Challenge Testing double-blind parallel randomized placebo cOntrolled tRial (PROSPECTOR) Studies are International, multi-centre randomised clinical trials being conducted across 6 countries and 14 participating centres:

Australia:

Austin Health (*Coordinating centre)

Peter MacCallum Cancer Centre

Royal Melbourne Hospital

St George Hospital

Royal North Shore Hospital

Royal Adelaide Hospital

Flinders Medical Centre

Royal Brisbane and Women's Hospital

Hong Kong:

Queen Mary Hospital

Canada:

McGill University Health Center

Montreal General Hospital

South Africa:

Groote Schuur Hospital

Denmark:

Herlev and Gentofte Hospital

Belgium:

Antwerp University Hospital

Study Objectives:

To evaluate whether prolonged oral challenge (5-day) is superior to single dose oral challenge in the investigation of patients reporting a penicillin allergy with a delayed or unknown onset of immune-mediated adverse reaction.

Ethics Approval and Study Progress:

The PROSPECTOR 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).

Trial registration number:

PROSPECTOR-1: ACTRN12623001242617

PROSPECTOR-2: ACTRN12624001107516

PROSPECTOR-1 study was a pilot feasibility study assessing the safety and feasibility of a placebo-controlled design to assess the superiority of prolonged oral challenge versus single dose challenge for identifying immune-mediated penicillin allergy. PROSPECTOR-1 was conducted across 4 sites in Australia (Austin Health, Peter MacCallum Cancer Centre, St George Hospital and Royal Brisbane and Women's Hospital), with 120 participants recruited.

The PROSPECTOR-2 study builds on the PROSECTOR-1 pilot feasibility trial, with planned recruitment of 712 participants.

Further information:

Please contact the PROSPECTOR Studies Project Manager - id.research@austin.org.au

Publications

Feasibility trial of prolonged vs single dose challenge in penicillin allergy.

(accepted for publication Jun 2025 - NEJM Evidence)

Rose MT, Vogrin S, Mitri E, De Luca J, Lapirow D, Reynolds GK, Hall R, McInnes K, James F, Ng I, Sullivan R, Lane M, Legg A, Copaescu A, Goh MS, Chua KYL, Holmes NE, Trubiano JA

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

BMJ Open. 2025 Feb 22;15(2):e094712. doi: 10.1136/bmjopen-2024-094712.

Ng I, James F, Copaescu A, Vogrin S, Mitri E, Rose M, Sullivan R, Lane M, Legg A, Godsell J, Fernando S, Garvey LH, Sabato V, Li P, Peter JG, Trubiano J