Evidence map›Paper›PMID 40911567›Full record

ArticlePloS one2025

International Network of Antibiotic Allergy Nations (iNAAN): Protocol for a type 2 hybrid effectiveness-implementation multicentre prospective cohort and target trial emulation study evaluating penicillin allergy delabeling via direct oral challenge.

Elise A Mitri, Luke R Fletcher, Camille Paynter, Sara Vogrin, Fiona James, Irvin Ng, Natasha E Holmes, Courtney Ierano, Jason A Roberts, Suran L Fernando and 2 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Direct Oral Challenge for Penicillin Allergy: A Hospital Implementation Evaluation Via the International Network of Antibiotic Allergy Nations (iNAAN) Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  3. Direct Oral Challenge for Penicillin Allergy: The International Network of Antibiotic Allergy Nations (iNAAN) Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Elise A MitriDepartment of Infectious Diseases, at the Peter Doherty Institute for Infection and Immunology, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-1250-2847
Luke R FletcherDepartment of Anaesthesia, Austin Health, Melbourne, Victoria, Australia.
Camille PaynterSchool of Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-1845-126X
Sara VogrinCentre for Antibiotic Allergy and Research, Department of Infectious Diseases and Immunology, Austin Health, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-1597-9421
Fiona JamesCentre for Antibiotic Allergy and Research, Department of Infectious Diseases and Immunology, Austin Health, Melbourne, Victoria, Australia.
Irvin NgCentre for Antibiotic Allergy and Research, Department of Infectious Diseases and Immunology, Austin Health, Melbourne, Victoria, Australia.
Natasha E HolmesDepartment of Infectious Diseases, at the Peter Doherty Institute for Infection and Immunology, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia.
Courtney IeranoDepartment of Infectious Diseases, at the Peter Doherty Institute for Infection and Immunology, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia.
Jason A RobertsUniversity of Queensland Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.
Suran L FernandoDepartment of Clinical Immunology and Allergy, Royal North Shore Hospital, St Leonards, New South Wales, Australia.
Marlena KlaicSchool of Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.
Jason A TrubianoDepartment of Infectious Diseases, at the Peter Doherty Institute for Infection and Immunology, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPenicillin allergies are reported in 1 in 10 hospitalised patients globally and are associated with inferior patient and health service outcomes. However, more than 95% of low-risk penicillin allergies can be removed by direct oral challenge (DOC).

objectiveThe International Network of Antibiotic Allergy Nations (iNAAN) aims to evaluate the utility of an audit and feedback (A&F) and education implementation strategy to increase the adoption of penicillin DOC in patients with a low-risk penicillin allergy, while concurrently assessing the impact of penicillin DOC on antibiotic prescribing and health service outcomes.

methodsThis is an international, multicentre type 2 hybrid effectiveness-implementation trial evaluating the widespread safety, clinical effectiveness and implementation of penicillin allergy delabeling via DOC, following penicillin allergy assessment using a purpose-built digital penicillin allergy toolkit within a smartphone application. The implementation strategy encompasses evaluation of co-designed digitally delivered bimonthly A&F reports to health services and clinicians, beginning a minimum of three months post site-activation, and optional education sessions that are delivered by the study team. The primary effectiveness outcome is the proportion of patients with a low-risk penicillin allergy that are delabeled following DOC. The primary implementation outcome is clinician adoption of the digital penicillin allergy toolkit within 6-months of site activation. Participants include adult patients who report a penicillin allergy and have undertaken a formalised penicillin allergy assessment, with or without DOC, at a participating health service. A target trial emulation approach will be used to analyse secondary effectiveness outcomes, including the impact of penicillin DOC on international antibiotic prescribing, infection-related and health service outcomes. DISCUSSION: This study protocol presents a type 2 hybrid effectiveness-implementation trial design that will provide high level evidence to aid widespread implementation of penicillin DOC.

trial registrationACTRN12623000484640 (https://www.anzctr.org.au/) (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385815&isReview=true).

Indexed as

Anti-Bacterial AgentsDrug HypersensitivityPenicillinsAdministration, OralHumansMulticenter Studies as TopicProspective StudiesAnti-Bacterial AgentsPenicillins

Identifiers

PMID40911567
PMCPMC12412947

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.