C-reactive protein testing in primary care and antibiotic use in children with acute respiratory tract infections in Kyrgyzstan: an open-label, individually randomised, controlled trial.

Background: Addressing the global antibacterial resistance crisis and aligning with the Kyrgyz Ministry of Health's research priorities, this study assesses the efficacy and safety of C-reactive protein (CRP) testing to guide antibiotic prescriptions in children with acute respiratory tract infections (ARTI) in Kyrgyzstan. Methods: In this open label individually randomised controlled trial, children aged 6 months to 12 years with ARTI in primary care settings were assigned to receive either standard care or standard care plus CRP testing. The study measured two primary outcomes: total antibiotic usage over a 14-day follow-up and caregiver-reported time to recovery. Follow-up assessments (days 3, 7, 14) were blinded. Trial registration: NCT05195866. Findings: A total of 1204 patients were randomised. Antibiotic use was lower in the CRP group (216/601, 36%) compared to the control group (362/603, 60%; Risk difference: 24 percentage points; 95% confidence interval (CI): 15-34). There was no significant difference in time to recovery (log-rank test p = 0.090) and the prespecified non-inferiority margin of one day was not exceeded. Hospital admissions were similar in both groups (CRP: 31 (5%), control: 26 (4%); odds ratio (OR) 1.20, 95% CI 0.69-2.10), but the CRP group re-consulted more often (OR 1.31, 95% CI 1.01-1.71) during the 14 days of follow-up. Interpretation: Implementing CRP testing in primary care for paediatric ARTI in Kyrgyzstan significantly reduced antibiotic use without negative effects on safety, supporting its role in national antimicrobial stewardship strategies. Funding: International Centre for Antimicrobial Resistance Solutions (ICARS).