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Efficacy and Safety of Procalcitonin Guidance in Patients With Suspected or Confirmed Sepsis

A Systematic Review and Meta-Analysis*

Iankova, Irena, PhD1; Thompson-Leduc, Philippe, MSc2; Kirson, Noam Y., PhD2; Rice, Bernie, BS3; Hey, Juliane, PharmD1; Krause, Alexander, PhD1; Schonfeld, Sophie A., BA2; DeBrase, Christopher R., BS2; Bozzette, Samuel, MD4; Schuetz, Philipp, MD5

doi: 10.1097/CCM.0000000000002928
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Objective: Sepsis is a leading cause of mortality in noncoronary ICUs. Although immediate start of antibiotics reduces sepsis-related mortality, antibiotics are often administered for too long, leading to suboptimal treatment and, importantly, contributes to antimicrobial resistance. Prior literature suggests that procalcitonin correlates with infection and thus may help to guide the decision on when to stop antibiotic treatment. This study was conducted as part of a regulatory submission to the U.S. Food and Drug Administration and aimed to summarize the evidence of procalcitonin guidance on efficacy and safety outcomes in adult patients with sepsis.

Data Sources: PubMed and the Cochrane Database of Systematic Reviews.

Study Selection: English-language randomized controlled trials evaluating procalcitonin use among adult patients with suspected or confirmed sepsis published between January 2004 and May 2016.

Data Extraction: Inverse-variance weighting fixed and random effects meta-analyses were performed on the following efficacy and safety endpoints: antibiotic duration, all-cause mortality, and length of ICU stay. Two reviewers independently extracted data elements from identified studies and measured risk of bias with the Cochrane Risk of Bias Tool.

Data Synthesis: From a total of 369 potentially eligible articles, 10 randomized controlled trials containing 3,489 patients were used for analysis. Procalcitonin-guided patients had shorter antibiotics duration compared with controls (7.35 vs. 8.85 d; weighted mean difference, –1.49 d; 95% CI, –2.27 to –0.71; p < 0.001). Procalcitonin use had no adverse impact on mortality (risk ratio, 0.90; 95% CI, 0.79–1.03; p = 0.114) and length of ICU stay (11.09 d vs. 11.91 d; weighted mean difference, –0.84 d; 95% CI, –2.52 to 0.84; p = 0.329).

Conclusions: In adult patients with suspected or confirmed sepsis, procalcitonin guidance reduces antibiotics duration with no observed adverse effects on patient outcomes.

1bioMérieux, Marcy-l’Étoile, France.

2Analysis Group Inc., Boston, MA.

3bioMérieux, Durham, NC.

4University of California, San Diego, CA.

5University of Basel, Switzerland.

*See also p. 811.

This work was performed at bioMérieux, Durham, NC.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (

Supported by bioMérieux SA. Dr. Iankova, Mr. Rice, and Drs. Hey, Krause, and Bozzette are employees or former employees of bioMérieux. Mr. Thompson-Leduc, Dr. Kirson, Ms. Schonfeld, and Mr. DeBrase are employees of Analysis Group, which has received consultancy fees from bioMérieux. Dr. Schuetz has received research funding from bioMérieux SA, Thermofisher, Roche, Siemens, and Abbott.

Drs. Iankova, Hey, Krause, and Bozzette, and Mr. Rice received funding from bioMérieux (employees or former employees). Drs. Kirson's and Schuetz's, Ms. Schonfeld's, Mr. Thompson-Leduc's, and Mr. DeBrase's institutions received funding from bioMérieux.

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