Abstract
Objectives: We aimed at assessing the efficacy and safety on antibiotics exposure of a strategy combining a respiratory multiplex PCR (mPCR) with enlarged panel and daily procalcitonin (PCT) measurements, as compared with a conventional strategy, in critically ill adult patients with laboratory-confirmed SARS-CoV-2 pneumonia.Methods: This multicentre, parallel-group, open-label, randomised controlled trial enrolled patients admitted to 13 intensive care units (ICU) in France. Patients were assigned (1:1) to the control strategy, where antibiotic streamlining remained at the discretion of the physicians, or interventional strategy, consisting of using mPCR and daily PCT measurements within the first seven days of randomisation to streamline initial antibiotic therapy, with antibiotic continuation encouraged when PCT was > 1 ng/mL and discouraged if < 1 ng/mL or decreased by 80% from baseline. All patients underwent conventional microbiological tests and cultures. The primary end-point was antibiotic-free days at day 28.Results: Between April 20st and November 23st 2020, 194 patients were randomised, of whom 191 were retained in the intention-to-treat analysis. Respiratory bacterial coinfection was detected in 48.4% (45/93) and 21.4% (21/98) in the interventional and control group, respectively. The number of antibiotic-free days was 12.0 (0.0; 25.0) and 14.0 (0.0; 24.0) days, respectively (difference -2.0, (95% CI -10.6 to 6.6), P=0.89). Superinfection rates were high (51.6% and 48.5%, respectively). Mortality rates and ICU lengths of stay did not differ between groups.Conclusion: In severe SARS-CoV-2 pneumonia, the mPCR/PCT algorithm strategy did not affect 28-day antibiotics exposure nor the major clinical outcomes, as compared with routine practice.