RT Journal Article
SR Electronic
T1 Procalcitonin levels to guide antibiotic therapy in adults with non-microbiologically proven apparent severe sepsis: a randomised controlled trial
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e002186
DO 10.1136/bmjopen-2012-002186
VO 3
IS 2
A1 Annane, Djillali
A1 Maxime, Virginie
A1 Faller, Jean Pierre
A1 Mezher, Chaouki
A1 Clec'h, Christophe
A1 Martel, Patricia
A1 Gonzales, Hélène
A1 Feissel, Marc
A1 Cohen, Yves
A1 Capellier, Gilles
A1 Gharbi, Miloud
A1 Nardi, Olivier
YR 2013
UL http://bmjopen.bmj.com/content/3/2/e002186.abstract
AB 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. Design This multicentre, randomised, controlled, single-blind trial was performed in two parallel groups. Setting Eight intensive care units in France. 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. Intervention The initiation and duration of antibiotic therapy was based on procalcitonin levels in the experimental arm and on the intensive care unit physicians’ clinical judgement without reference to procalcitonin values in the control arm. Main outcome measure The primary outcome was the proportion of patients on antibiotics on day 5 postrandomisation. 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 <0.25 µg/l; in these patients, physician complied poorly with the algorithm. 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.