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

Mesh : Anti-Bacterial Agents / therapeutic use Biomarkers / blood Calcitonin / blood Calcitonin Gene-Related Peptide Decision Making Emergency Service, Hospital Female Humans Male Outcome and Process Assessment, Health Care Practice Guidelines as Topic Protein Precursors / blood Research Design Respiratory Tract Infections / drug therapy Treatment Outcome United States

来  源:   DOI:10.1186/s12873-017-0138-1   PDF(Sci-hub)   PDF(Pubmed)

Abstract:
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.
摘要:
抗生素的过度使用是一个主要的公共卫生问题,增加抗生素耐药性。据报道,降钙素原在细菌中通常升高,但不是病毒感染.多项欧洲试验发现,降钙素原指导的护理减少了下呼吸道感染中抗生素的使用,没有明显的伤害。然而,由于试验设计特点在美国不切实际,对美国实践的适用性有限,国家之间的差异,和剩余的安全问题。
降钙素原抗生素共识试验(ProACT)是一项多中心随机试验,旨在确定降钙素原抗生素处方指南的影响。用基本的可重复策略实施,美国下呼吸道感染患者。
我们使用合并报告试验标准(CONSORT)框架描述试验方法,以及关键设计决策的基本原理,包括资格标准的选择,控制臂的选择,以及指导方针实施的方法。
ClinicalTrials.govNCT02130986。2014年5月1日注册
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