Feasibility of a clinical trial comparing point-of-care procalcitonin and C-reactive protein testing in primary care to decrease antibiotic prescription in patients with acute respiratory infections

This pilot project addresses the urgent need to reduce unnecessary antibiotic prescriptions for acute respiratory tract infections (ARIs) in primary care. Although point-of-care (POC) biomarkers like C-reactive protein (CRP) and procalcitonin (PCT) have shown promise in guiding antibiotic decisions, no direct comparison between the two exists. This evidence gap limits informed decision-making and has led to the rejection of PCT reimbursement by Swiss authorities due to its higher cost and lack of comparative data.
The proposed study, titled PCT-CRP Pilot, aims to assess the feasibility of a full-scale randomized clinical trial comparing CRP and PCT testing in primary care settings. The pilot will evaluate operational aspects such as recruitment, randomization, test implementation, and acceptability among healthcare professionals and patients. It will be conducted in two primary care centers—one in French-speaking and one in German-speaking Switzerland.
Study population includes patients aged 16+ presenting with symptoms of acute respiratory infection, predominantly cough, where antibiotics are being considered. Two patient categories will be included: those with intermediate to high likelihood of benefiting from antibiotics per Swiss Society for Infectious Diseases (SSI) guidelines, and those outside strict criteria but still considered for antibiotics by physicians. Exclusion criteria include severe illness requiring hospitalization, immunosuppression, or inability to complete follow-up.
Study procedures involve training healthcare professionals, screening and informed consent, randomization via sealed envelopes, immediate POC testing, and clinical decision-making guided by SSI recommendations. Follow-up includes patient diaries and a phone call at day 28.
Primary outcomes focus on feasibility, appropriateness, and acceptability of study procedures, rated by professionals. Secondary outcomes include recruitment and consent rates, protocol adherence, clinical outcomes (antibiotic use and recovery), and qualitative feedback on barriers to study implementation.
The pilot aims to recruit 20–30 patients and 10 primary care professionals. Data collection will use electronic case report forms and patient e-diaries.
Expected benefits include generating important data to ensure feasibility for a larger pivotal trial. Conducting the study in real-world primary care settings ensures relevance and transferability of results.