Prevalence and clinical impact of the label ‘beta-lactam allergy’ in APHP hospitals: a cross-sectional study based on health data from a single day BETALL

Study identification

• EU PAS number:
  EUPAS1000000897
• Study ID:
  1000000897
• Official title and acronym:
  Prevalence and clinical impact of the label ‘beta-lactam allergy’ in APHP hospitals: a cross-sectional study based on health data from a single day BETALL
• DARWIN EU® study:
  Yes
• Study countries:
  France
• Study description:
  Beta-lactam allergy is the most frequently reported drug hypersensitivity. Yet its true prevalence is largely overestimated: although 5–15% of adults declare penicillin allergy, fewer than 10% are confirmed after testing. Incorrect allergy labels lead to inappropriate antibiotic choices, longer hospital stays, higher risk of treatment failure, C. difficile infection, and antimicrobial resistance. Improving documentation accuracy is therefore a key public health priority.; This study aims to (1) estimate the prevalence of documented beta-lactam allergy within AP-HP; (2) assess the proportion of confirmed allergies; (3) evaluate the quality of EHR documentation; and (4) analyse the impact of allergy labels on antibiotic prescribing.; We will conduct a one-day cross-sectional study using the AP-HP Health Data Warehouse. All adults (≥18 years) hospitalised or seen on 14 December 2022 in ORBIS-enabled hospitals will be included, except psychiatry, rehabilitation, emergency, and critical care units. Allergy information will be identified through structured EHR fields, PMSI coding, and text-mining of clinical notes. Descriptive analyses and bootstrap confidence intervals will estimate prevalence, with subgroup analyses by hospital, specialty, age, and sex.; This study will provide the first large-scale estimate of beta-lactam allergy labelling at AP-HP, highlight gaps in documentation and confirmation, and support interventions to improve antimicrobial stewardship and patient safety.
• Study status:
  Planned

Research institutions and networks

Institutions

Centre de pharmaco-épidémiologie (Paris Pharmacoepidemiology Centre), Assistance Publique, Hôpitaux de Paris

France

Study timelines

Date when funding contract was signed

Actual:01/07/2024

Study start date

Planned:14/12/2022

Data analysis start date

Planned:20/09/2025

Date of final study report

Planned:01/09/2026

Sources of funding

Other

More details on funding

Government body: DGOS

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable