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

on behalf of the ProACT Investigators¹  Donald M. Yealy²  Jonathan Yabes³  Michael J. Fine³  Yohei Doi⁴  Francis Pike⁵  Lisa A. Weissfeld⁶  David T. Huang⁷  Chung-Chou H. Chang⁷  Derek C. Angus⁷  John A. Kellum⁷  Octavia M. Peck-Palmer⁷ 

[1] ;Department of Emergency Medicine, University of Pittsburgh;Division of General Internal Medicine, University of Pittsburgh;Division of Infectious Diseases, University of Pittsburgh;Eli Lilly and Company;Statistics Collaborative, Inc.;The CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) Center;

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

DOI  :  10.1186/s12873-017-0138-1

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown