Lancet RCT: CRP Point-of-Care Decision Tool Safely Cuts Pediatric Antibiotic Prescribing by 28%
The ARON trial, a pragmatic cluster-randomized controlled trial across Belgian primary care practices, demonstrated that a clinical decision tool combining a validated decision tree, point-of-care CRP testing, and safety-netting advice reduced antibiotic prescribing in acutely ill children from 22% to 16% without increasing recovery time or adverse events. With nearly 7,000 participants, this is the largest trial of its kind and provides strong evidence for broader implementation of POC CRP-guided antibiotic stewardship in pediatric ambulatory care.
The original study
A clinical decision tool including a decision tree, point-of-care testing of CRP, and safety-netting advice to guide antibiotic prescribing in acutely ill children in primary care in Belgium (ARON): a pragmatic, cluster-randomised, controlled trial.
- Authors
- Verbakel JY, Burvenich R, D'hulster E, De Rop L, Van den Bruel A, Anthierens S, et al.
- Journal
- Lancet (London, England)
- Type
- Journal Article, Randomized Controlled Trial, Multicenter Study, Pragmatic Clinical Trial
- PMID
- 41016406
Original abstract
BACKGROUND: Antimicrobial resistance is a global health threat. Many children with acute illness in ambulatory care are unnecessarily prescribed antibiotics. We assessed the clinical effectiveness of a clinical decision tool for these children, including a validated decision tree, guided point-of-care C-reactive protein testing (POCT of CRP), and safety-netting advice. METHODS: ARON was a multicentre, unblinded, pragmatic, cluster-randomised, controlled trial conducted at eligibile Belgian general practitioner and community paediatrician practices able to recruit children with acute illness consecutively, and not already doing POCT of CRP. Practices were allocated (1:1) with equal size (n=4) block randomisation to the clinical decision tool or usual care, stratified by recruiting academic centre. Children with acute illness aged 6 months to 12 years were recruited and followed up for 30 days. The coprimary outcomes were antibiotic prescribing at the index consultation (tested for superiority), as well as recovery time, additional testing, follow-up visits, and antibiotic prescribing after index consultation (all tested for non-inferiority with margins of 1 day, 3%, 4%, and 2%, respectively). Coprimary outcomes were analysed with logistic regression, accounting for practice clustering, study arm, and age in the intention-to-treat population, except recovery time, which was analysed with Cox regression adjusting for the same covariates. Safety was assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT04470518) and is completed. FINDINGS: Of 171 eligible practices, we randomly allocated 82 to the intervention group and 89 to the usual care group. Between Feb 24, 2021, and Dec 29, 2023, 7049 participants were screened, of whom 6760 were deemed eligible. Five patients in each study arm were excluded, so we analysed data from 6750 participants (2988 in the intervention group and 3762 in the control group; 3447 [51%] boys, 3302 [49%] girls, one [<1%] did not specify). The intervention significantly reduced antibiotic prescribing at the index consultation (466 [16%] vs 817 [22%], adjusted odds ratio 0·72 [95% CI 0·55-0·94]; p=0·017). Recovery time (adjusted mean difference -0·1 day [95% CI -0·5 to 0·3]), additional testing (adjusted absolute risk reduction [aARR] 2·0% [-1·7 to 5·0]), follow-up visits (aARR 2·8% [-0·9 to 6·1]), and antibiotic prescribing after index consultation (aARR 2·4% [0·2 to 4·2]) were all non-inferior in the intervention group versus the control group. 90 (88%) of 102 adverse events were serious (30 [1%] in the intervention group and 60 [2%] in the control group); none were deemed related to the study procedures. No child died throughout the trial. INTERPRETATION: The clinical decision tool reduced antibiotic prescribing in children without causing harm. Our results support its broader dissemination and implementation to improve the management of acutely ill children in ambulatory care. FUNDING: Belgian Health Care Knowledge Centre.