Procalcitonin for selecting the antibiotic regimen in outpatients with low-risk community-acquired pneumonia using a rapid point-of-care testing: A single-arm clinical trial

ObjectiveWe aimed to assess the role of procalcitonin (PCT) to guide the initial selection of the antibiotic regimen for low-risk community-acquired pneumonia (CAP).MethodsA single-arm clinical trial was conducted including outpatients with CAP and Pneumonia Severity Index risk classes I-II. Antimicrobial selection was based on the results of PCT measured with a rapid point-of-care testing. According to serum PCT levels, patients were assigned to two treatment strategies: oral azithromycin if PCT was ResultsOf 253 subjects included, 216 (85.4%) were assigned to azithromycin. Pneumococcal infection was diagnosed in 26 (12%) and 21 (56.8%) patients allocated to azithromycin and levofloxacin groups, respectively. No patients in the azithromycin group developed bacteraemia. Atypical organisms were more common in patients given azithromycin (18.5% vs 8.1%, respectively). The majority (93%) of patients with atypical pneumonia had low PCT levels. Clinical cure rates were 95.8% in the azithromycin group, 94.6% in the levofloxacin group, and 94.4% in the historical control group. No 30-day mortality or recurrences were observed, and the 3-year rates of recurrence and mortality were very low in both groups. Adverse events occurrence was also infrequent.ConclusionA PCT-guided strategy with a rapid point-of-care testing safely allowed selecting empirical narrow-spectrum antibiotics in outpatients with CAP.Trial registrationThe study is registered with ClinicalTrials.gov, number NCT02600806