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

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 r...

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Bibliographic Details
Published in:BMC emergency medicine Vol. 17; no. 1; pp. 25 - 10
Main Authors: 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.
Format: Journal Article
Language:English
Published: London BioMed Central 29.08.2017
BioMed Central Ltd
Springer Nature B.V
BMC
Subjects:
Anti-bacterial agents
Anti-Bacterial Agents - therapeutic use
Antibiotic resistance
Antibiotics
Asthma
Bacterial infections
Biomarkers
Biomarkers - blood
Calcitonin - blood
Calcitonin Gene-Related Peptide
Chronic obstructive pulmonary disease
Clinical decision making
Clinical medicine
Clinical trial
Clinical trials
Decision Making
Drug resistance in microorganisms
Drug therapy
Emergency medical care
Emergency Medicine
Emergency Service, Hospital
Enrollments
Evidence-based medicine
Female
General emergency medicine
Health aspects
Hospitalization
Humans
Infections
Male
Medicine
Medicine & Public Health
Methods
Methods (MeSH)
Outcome and Process Assessment, Health Care
Patients
Physicians
Pneumonia
Practice Guidelines as Topic
Procalcitonin
Protein Precursors - blood
Public health
Research Design
Respiratory tract diseases
Respiratory tract infection
Respiratory tract infections
Respiratory Tract Infections - drug therapy
Risk factors
Study Protocol
Treatment Outcome
United States
Ventilators
Viral infections
United States
United States > US
Respiratory tract infections
Biomarkers
Clinical trial
Methods (MeSH)
Anti-bacterial agents
Procalcitonin
ISSN:1471-227X, 1471-227X
Online Access:Get full text
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Description
Summary: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.
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ISSN:1471-227X
1471-227X
DOI:10.1186/s12873-017-0138-1