Procalcitonin levels to guide antibiotic therapy in adults with non-microbiologically proven apparent severe sepsis: a randomised controlled trial

作者：Annane Djillali^*; Maxime Virginie; Faller Jean Pierre; Mezher Chaouki; Clec' h Christophe; Martel Patricia; Gonzales Helene; Feissel Marc; Cohen Yves; Capellier Gilles; Gharbi Miloud; Nardi Olivier

来源：BMJ Open, 2013, 3(2): e002186.

DOI：10.1136/bmjopen-2012-002186

Objective: Some patients with the phenotype of severe sepsis may have no overt source of infection or identified pathogen. We investigated whether a procalcitonin-based algorithm influenced antibiotic use in patients with non-microbiologically proven apparent severe sepsis. %26lt;br%26gt;Design: This multicentre, randomised, controlled, single-blind trial was performed in two parallel groups. %26lt;br%26gt;Setting: Eight intensive care units in France. %26lt;br%26gt;Participants: Adults with the phenotype of severe sepsis and no overt source of infection, negative microbial cultures from multiple matrices and no antibiotic exposure shortly before intensive care unit admission. %26lt;br%26gt;Intervention: The initiation and duration of antibiotic therapy was based on procalcitonin levels in the experimental arm and on the intensive care unit physicians%26apos; clinical judgement without reference to procalcitonin values in the control arm. %26lt;br%26gt;Main outcome measure: The primary outcome was the proportion of patients on antibiotics on day 5 postrandomisation. %26lt;br%26gt;Results: Over a 3-year period, 62/1250 screened patients were eligible for the study, of whom 31 were randomised to each arm; 4 later withdrew their consent. At day 5, 18/27 (67%) survivors were on antibiotics in the experimental arm, versus 21/26 (81%) controls (p= 0.24; relative risk= 0.83, 95% CI: 0.60 to 1.14). Only 8/58 patients (13%) had baseline procalcitonin %26lt;0.25 mu g/l; in these patients, physician complied poorly with the algorithm. %26lt;br%26gt;Conclusions: In intensive care unit patients with the phenotype of severe sepsis or septic shock and without an overt source of infection or a known pathogen, the current study was unable to confirm that a procalcitonin-based algorithm may influence antibiotic exposure. However, the premature termination of the trial may not allow definitive conclusions.

• 出版日期2013