Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection

David T Huang, Derek C Angus, Chung-Chou H Chang, Yohei Doi, Michael J Fine, John A Kellum, Octavia M Peck-Palmer, Francis Pike, Lisa A Weissfeld, Jonathan Yabes, Donald M Yealy, ProACT Investigators, Michael Donnino, Peter Hou, Robert Sherwin, John Holst, Colleen Rafferty, Daniel Rodgers, William Dachman, Frank LoVecchio, Michael Filbin, Jonathan Fine, Jean Hammel, Matthew Exline, Lauren Southerland, Michael Kurz, David McCullum, Shahram Lotfipour, Gentry Wilkerson, Heather Prunty, Brian Suffoletto, Aaron Brown, Franziska Jovin, David T Huang, Derek C Angus, Chung-Chou H Chang, Yohei Doi, Michael J Fine, John A Kellum, Octavia M Peck-Palmer, Francis Pike, Lisa A Weissfeld, Jonathan Yabes, Donald M Yealy, ProACT Investigators, Michael Donnino, Peter Hou, Robert Sherwin, John Holst, Colleen Rafferty, Daniel Rodgers, William Dachman, Frank LoVecchio, Michael Filbin, Jonathan Fine, Jean Hammel, Matthew Exline, Lauren Southerland, Michael Kurz, David McCullum, Shahram Lotfipour, Gentry Wilkerson, Heather Prunty, Brian Suffoletto, Aaron Brown, Franziska Jovin

Abstract

Background: Overuse of antibiotics is a major public health problem, contributing to growing antibiotic resistance. Procalcitonin has been reported to be commonly elevated in bacterial, but not viral infection. Multiple European trials found procalcitonin-guided care reduced antibiotic use in lower respiratory tract infection, with no apparent harm. However, applicability to US practice is limited due to trial design features impractical in the US, between-country differences, and residual safety concerns.

Methods: The Procalcitonin Antibiotic Consensus Trial (ProACT) is a multicenter randomized trial to determine the impact of a procalcitonin antibiotic prescribing guideline, implemented with basic reproducible strategies, in US patients with lower respiratory tract infection.

Discussion: We describe the trial methods using the Consolidated Standards of Reporting Trials (CONSORT) framework, and the rationale for key design decisions, including choice of eligibility criteria, choice of control arm, and approach to guideline implementation.

Trial registration: ClinicalTrials.gov NCT02130986 . Registered May 1, 2014.

Keywords: Anti-bacterial agents; Biomarkers; Clinical trial; Methods (MeSH); Procalcitonin; Respiratory tract infections.

Conflict of interest statement

Ethics approval and consent to participate

The University of Pittsburgh Institutional Review Board approved the ProACT trial.

Consent for publication

Not applicable.

Competing interests

David T. Huang receives grant funding from ThermoFisher for a study examining the microbiome in lower respiratory tract infection.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
ProACT guidelines. The ProACT Coordinating Center provided posters of this Figure to all centers. Other study education, in-service training, and promotion materials contain the same content

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