Rapid Respiratory Microbiological Point-of-Care Testing and Antibiotic Use in Primary Care: A Randomized Clinical Trial.

importanceMost antibiotic prescribing takes place in primary care, driving antimicrobial resistance, a top-10 threat to global public health. There is considerable international interest in whether rapid multiplex microbiological point-of-care testing (RM-POCT) can safely reduce antibiotic prescribing in primary care.

objectiveTo investigate whether the use of a RM-POCT can safely reduce same-day antibiotic prescribing for children and adults presenting to primary care with respiratory infections. DESIGN, SETTING, AND

participantsThis parallel-group randomized clinical trial was conducted at 16 general practices in Southwest England between December 2022 and April 2024. Patients were eligible if they were aged 12 months or older, presented with any clinician-diagnosed acute (≤21 days) respiratory tract infection, and the patient or clinician believed antibiotic treatment was, or might be, necessary. Participants were randomized (1:1) to RM-POCT or usual care. The research team, including those conducting statistical analyses, were unaware of group allocation. Data were analyzed from November 21, 2024, to March 13, 2025.

interventionPatients in the intervention group were tested with RM-POCT to indicate the presence or absence of 19 respiratory viral pathogens and 4 atypical bacteria in approximately 45 minutes. MAIN OUTCOMES AND MEASURES: The primary outcome was same-day antibiotic prescribing. The safety outcome was patient-reported symptom severity on days 2 to 4.

resultsAmong 552 included patients (mean [SD] age, 40.0 [21.2] years; 349 [63%] female), 276 were randomized to the intervention group and 276 to usual care. Primary outcome data were available for all participants, and safety outcome data were available in 216 intervention participants (78%) and 203 usual care participants (74%). Same-day antibiotics were prescribed to 124 participants (45%) in each group (odds ratio [OR], 1.00 [95% CI, 0.71 to 1.41]; P > .99). Prespecified subgroup analyses showed evidence of differentially reduced antibiotic prescribing in participants from whom a virus was detected (OR, 0.35 [95% CI, 0.20 to 0.63]; P for interaction < .001) and those with chronic lung disease (OR, 0.55 [95% CI, 0.28 to 1.09]; P for interaction = .046) but not children younger than 16 years (OR, 1.75 [95% CI, 0.64 to 4.74]; P for interaction = .24), nor where patients and clinicians disagreed on antibiotic necessity (OR, 1.12 [95% CI, 0.63 to 1.98]; P for interaction = .53). There was no difference in symptom severity on days 2 to 4 between groups (difference in means, 0.09 [95% CI, -0.10 to 0.27]; P = .36). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial among patients with respiratory tract infections being considered for antibiotic treatment in primary care, use of an RM-POCT did not reduce same-day antibiotic prescribing or worsen patient outcomes. Trial Registration: isrctn.org Identifier: ISRCTN16039192.