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An audit of antibiotic allergy assessment and test-dose challenge in hospitalised paediatric patients using a patient registry.

International Network of Antibiotic Allergy Nations - Kids: A prospective type 2 hybrid effectiveness-implementation cohort study evaluating the safety and effectiveness of direct challenge in hospitalised paediatric patients with a low risk antibiotic allergy and an Audit and Feedback implementation strategy in participating health services.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625001328460
Acronym
iNAAN-Kids
Enrollment
400
Registered
2025-11-28
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patient-reported antibiotic allergy labels are a major public health concern with an estimated 18% of all hospitalised Australians reporting an antibiotic allergy. In one study, the prevalence of paediatric antibiotic allergy labels was 5.3%, with an increasing incidence of reported antibiotic allergy labels with age. Paediatric inpatients with an antibiotic allergy are more likely to receive inferior antibiotics and those reporting a beta-lactam allergy are more likely to have a prolonged hospital length of stay. In the paediatric population, penicillin direct oral challenge has been demonstrated to be a safe delabelling strategy in the outpatient setting, however the safety and effectiveness of paediatric inpatient direct oral challenge and its subsequent impact on antibiotic prescribing and antimicrobial resistance is ill-defined. Furthermore, a national implementation strategy for an effective paediatric antibiotic allergy toolkit has not been previously published. We seek to prospectively audit implementation of paediatric clinical antibiotic allergy delabelling programs, via the International Network of Antibiotic Allergy Nations (iNAAN) platform, to assess safety and the subsequent effects of antibiotic allergy delabelling on antibiotic prescribing and patient outcomes.

Interventions

Paediatric (age < 18 years) patients who have a documented antibiotic allergy label will be identified by site investigators in the inpatient, outpatient and day unit setting at participating hospitals. Antibiotic allergy labels include those from the following antibiotic classes: penicillins, cephalosporins, sulfonamide antibiotics or 'sulfonamide/sulfa unspecified'. Identified patients with an antibiotic allergy label will undergo a formal antibiotic allergy assessment using a digital antibiot

Paediatric (age < 18 years) patients who have a documented antibiotic allergy label will be identified by site investigators in the inpatient, outpatient and day unit setting at participating hospitals. Antibiotic allergy labels include those from the following antibiotic classes: penicillins, cephalosporins, sulfonamide antibiotics or 'sulfonamide/sulfa unspecified'. Identified patients with an antibiotic allergy label will undergo a formal antibiotic allergy assessment using a digital antibiotic allergy assessment tool and/or according to the local health service antibiotic allergy assessment protocol. EFFECTIVENESS INTERVENTION: Patients identified as having a low-risk penicillin, cephalosporin or sulfonamide allergy will be offered a direct challenge ("effectiveness intervention"), as part of standard clinical practice, in accordance with the local health service protocol for allergy evaluation. The direct challenge is offered to low-risk patients, regardless of participation in the study. Patients who have a negative challenge outcome will be delabelled of their antibiotic allergy. Patient demographic data (age, sex, ethnicity), medical co-morbidities, antibiotic allergy phenotype and challenge data (if performed) will be collected by the National Antibiotic Allergy Network (NAAN) smartphone app with secure upload to a iNAAN REDCap database, hosted by BioGrid. The NAAN app is accessible only by participating health service study teams. Data is entered into the NAAN app by multi-disciplinary clinicians (Medical, Nursing, Pharmacy) who are part of the site project team. Additional data, including hospital admission data, antibiotic usage pre- and post- antibiotic allergy evaluation and antibiotic adverse events may also be entered into the REDCap database for up to 12 months post-antibiotic allergy evaluation. IMPLEMENTATION INTERVENTION: Clinicians at participating health services will receive digital audit and feedback (A&F) ("implementation strategy"), known as the iNAAN-Kids Health Service Report (HSR). The iNAAN-Kids HSR will contain aggregate, deidentified data detailing the local clinical effectiveness and implementation outcomes of antibiotic allergy evaluation, with hospital level benchmarking. The iNAAN-Kids HSR will be delivered digitally every 8 weeks, beginning 12-weeks post site-activation. The effect of digital A&F on ongoing adoption of the digital antibiotic allergy toolkit to perform assessment, and the sustainability of direct challenge in paediatric health services will be audited. This includes an audit of the number of antibiotic allergy assessments and direct challenges performed throughout the study period, both without A&F (baseline 12 weeks) and with A&F (every 8 weeks, from 12 weeks post-activation). Note: The digital antibiotic allergy toolkit and implementation strategy will remain the same throughout the study period.

Sponsors

Austin Health
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No

Inclusion criteria

Patients < 18 years of age reporting a penicillin, cephalosporin and/or sulfonamide antibiotic allergy.

Exclusion criteria

Nil

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026