학술논문

Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection
Document Type
article
Source
BMC Emergency Medicine. 17(1)
Subject
Medical Microbiology
Biomedical and Clinical Sciences
Lung
Clinical Research
Infectious Diseases
Clinical Trials and Supportive Activities
Infection
Anti-Bacterial Agents
Biomarkers
Calcitonin
Calcitonin Gene-Related Peptide
Decision Making
Emergency Service
Hospital
Female
Humans
Male
Outcome and Process Assessment
Health Care
Practice Guidelines as Topic
Protein Precursors
Research Design
Respiratory Tract Infections
Treatment Outcome
United States
ProACT Investigators
Anti-bacterial agents
Clinical trial
Methods
Procalcitonin
Respiratory tract infections
Clinical Sciences
Emergency & Critical Care Medicine
Clinical sciences
Health services and systems
Language
Abstract
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.