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

BMC Emergency Medicine

Study Protocol

Donald M. Yealy¹  Jonathan Yabes²  Michael J. Fine³  Yohei Doi⁴  Francis Pike⁵  Lisa A. Weissfeld⁶  John A. Kellum⁷  David T. Huang⁸  Derek C. Angus⁹  Octavia M. Peck-Palmer^1,10  Chung-Chou H. Chang^1,11 

[1] Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA;The MACRO (Multidisciplinary Acute Care Research Organization) Center, Pittsburgh, PA, USA;Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA;Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA;Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA;Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, PA, USA;Eli Lilly and Company, Indianapolis, IN, USA;Statistics Collaborative, Inc., Washington, DC, USA;The CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) Center, Pittsburgh, PA, USA;Department of Critical Care Medicine, University of Pittsburgh, Room 606B Scaife Hall, 3550 Terrace Street, 15261, Pittsburgh, PA, USA;The CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) Center, Pittsburgh, PA, USA;Department of Critical Care Medicine, University of Pittsburgh, Room 606B Scaife Hall, 3550 Terrace Street, 15261, Pittsburgh, PA, USA;Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA;The MACRO (Multidisciplinary Acute Care Research Organization) Center, Pittsburgh, PA, USA;The CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) Center, Pittsburgh, PA, USA;Department of Critical Care Medicine, University of Pittsburgh, Room 606B Scaife Hall, 3550 Terrace Street, 15261, Pittsburgh, PA, USA;The MACRO (Multidisciplinary Acute Care Research Organization) Center, Pittsburgh, PA, USA;The CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) Center, Pittsburgh, PA, USA;Department of Pathology, University of Pittsburgh, Pittsburgh, PA, USA;The CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) Center, Pittsburgh, PA, USA;Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA;

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

DOI  :  10.1186/s12873-017-0138-1

 received in 2017-07-21, accepted in 2017-08-09,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundOveruse 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.MethodsThe 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.DiscussionWe 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 registrationClinicalTrials.gov NCT02130986. Registered May 1, 2014.

【 授权许可】

CC BY   
© The Author(s). 2017