Huang David T, Angus Derek C, Chang Chung-Chou H, Doi Yohei, Fine Michael J, Kellum John A, Peck-Palmer Octavia M, Pike Francis, Weissfeld Lisa A, Yabes Jonathan, Yealy Donald M
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, Pittsburgh, PA, 15261, USA.
BMC Emerg Med. 2017 Aug 29;17(1):25. doi: 10.1186/s12873-017-0138-1.
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.
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.
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.
ClinicalTrials.gov NCT02130986 . Registered May 1, 2014.
抗生素的过度使用是一个重大的公共卫生问题，导致抗生素耐药性不断增加。据报道，降钙素原在细菌感染而非病毒感染中通常会升高。多项欧洲试验发现，降钙素原指导的治疗可减少下呼吸道感染中的抗生素使用，且无明显危害。然而，由于试验设计特点在美国不实用、国家间差异以及残留的安全问题，其在美国实践中的适用性有限。
降钙素原抗生素共识试验（ProACT）是一项多中心随机试验，旨在确定一项降钙素原抗生素处方指南在美国下呼吸道感染患者中实施的影响，该指南采用基本可重复的策略。
我们使用试验报告统一标准（CONSORT）框架描述试验方法，以及关键设计决策的理由，包括入选标准的选择、对照臂的选择和指南实施方法。
ClinicalTrials.gov NCT02130986。2014年5月1日注册。
