TY - JOUR
T1 - 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)
T2 - Implications for healthcare systems
AU - Krishna, Mamidipudi Thirumala
AU - Bhogal, Rashmeet
AU - Ng, Bee Yean
AU - Kildonaviciute, Kornelija
AU - Jani, Yogini H.
AU - Williams, Iestyn
AU - Sandoe, Jonathan A.T.
AU - Pollard, Rachel
AU - Jones, Nicola
AU - Dunsmure, Louise
AU - Powell, Neil
AU - Hullur, Chidanand
AU - Balaji, Ariyur
AU - Moriarty, Catherine
AU - Jackson, Beverley
AU - Warner, Amena
AU - Daniels, Ron
AU - West, Robert
AU - Thomas, Caroline
AU - Misbah, Siraj A.
AU - Savic, Louise
N1 - Publisher Copyright:
© 2024 The Authors
Funder: NIHR HS&DR; NIHR129069.
PY - 2024/3
Y1 - 2024/3
N2 - 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.
AB - 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.
KW - Antimicrobial resistance
KW - Direct oral penicillin challenge
KW - High risk
KW - Low risk
KW - Penicillin allergy
KW - Risk stratification
UR - http://www.scopus.com/inward/record.url?scp=85185290639&partnerID=8YFLogxK
U2 - 10.1016/j.jinf.2024.01.015
DO - 10.1016/j.jinf.2024.01.015
M3 - Article
C2 - 38331329
AN - SCOPUS:85185290639
SN - 0163-4453
VL - 88
JO - Journal of Infection
JF - Journal of Infection
IS - 3
M1 - 106116
ER -