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.

Abstract

OBJECTIVE:We aimed to assess the role of procalcitonin (PCT) to guide the initial selection of the antibiotic regimen for low-risk community-acquired pneumonia (CAP). METHODS:A 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 <0.5 ng/ml, or levofloxacin if levels were ≥0.5 ng/ml. Primary outcome was clinical cure rate. Short-term and long-term outcomes were assessed. Results were compared with those of a historical standard-of-care control-group treated in our centre. RESULTS:Of 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. CONCLUSION:A PCT-guided strategy with a rapid point-of-care testing safely allowed selecting empirical narrow-spectrum antibiotics in outpatients with CAP. TRIAL REGISTRATION:The study is registered with ClinicalTrials.gov, number NCT02600806.