A multicentre observational study to investigate feasibility of a direct oral penicillin challenge in de-labelling ‘low risk’ patients with penicillin allergy by non-allergy healthcare professionals (SPACE study): Implications for healthcare systems

Mamidipudi Thirumala Krishna*, Rashmeet Bhogal, Bee Yean Ng, Kornelija Kildonaviciute, Yogini H. Jani, Iestyn Williams, Jonathan A.T. Sandoe, Rachel Pollard, Nicola Jones, Louise Dunsmure, Neil Powell, Chidanand Hullur, Ariyur Balaji, Catherine Moriarty, Beverley Jackson, Amena Warner, Ron Daniels, Robert West, Caroline Thomas, Siraj A. MisbahLouise Savic

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Abstract

Objective: The huge burden of inaccurate penicillin allergy labels (PALs) is an important driver of antimicrobial resistance. This is magnified by insufficient allergy specialists and lack of ‘point-of-care’ tests. We investigated the feasibility of non-allergy healthcare professionals (HCPs) delivering direct oral penicillin challenges (DPCs) for penicillin allergy de-labelling. 

Methods: This prospective observational study was conducted in three hospitals in England across three settings (acute medical, pre-surgical and haematology-oncology). Patients with a PAL were screened and stratified as low risk/high risk. Low risk patients (non-immune mediated symptoms, benign rash, tolerated amoxicillin since and family history) underwent a DPC. 

Results: N = 2257 PALs were screened, 1054 were eligible; 643 were approached, 373 declined, 270 consented and 259 risk stratified (low risk = 155; high risk = 104). One hundred and twenty-six low risk patients underwent DPC, 122 (96.8%) were de-labelled with no serious allergic reactions. Conversion rate from screening-to-consent was 12% [3.3% and 17.9% in acute and elective settings respectively; odds ratios for consent were 3.42 (p < 0.001) and 5.53 (p < 0.001) in haematology-oncology and pre-surgical setting respectively. Common reasons for failure to progress in the study included difficulty in reaching patients, clinical instability/medical reasons, lacking capacity to consent and psychological factors. 

Interpretation: DPCs can be delivered by non-allergy HCPs. A high proportion of patients with PALs did not progress in the study pathway. Strategies to deliver DPC at optimal points of the care pathway are needed to enhance uptake. Elective settings offer greater opportunities than acute settings for DPC. The safety and simplicity of DPCs lends itself to adoption by healthcare systems beyond the UK, including in resource-limited settings.

Original languageEnglish
Article number106116
JournalJournal of Infection
Volume88
Issue number3
Early online date6 Feb 2024
DOIs
Publication statusPublished - Mar 2024

Bibliographical note

Publisher Copyright:
© 2024 The Authors

Funder: NIHR HS&DR; NIHR129069.

Keywords

  • Antimicrobial resistance
  • Direct oral penicillin challenge
  • High risk
  • Low risk
  • Penicillin allergy
  • Risk stratification

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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