Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection
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 i...
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doaj-b6eef931e758491ba908541572b4bbb12020-11-24T23:58:53ZengBMCBMC Emergency Medicine1471-227X2017-08-0117111010.1186/s12873-017-0138-1Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infectionDavid T. Huang0Derek C. Angus1Chung-Chou H. Chang2Yohei Doi3Michael J. Fine4John A. Kellum5Octavia M. Peck-Palmer6Francis Pike7Lisa A. Weissfeld8Jonathan Yabes9Donald M. Yealy10on behalf of the ProACT InvestigatorsThe CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) CenterThe CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) CenterThe CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) CenterDivision of Infectious Diseases, University of PittsburghDivision of General Internal Medicine, University of PittsburghThe CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) CenterThe CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) CenterEli Lilly and CompanyStatistics Collaborative, Inc.Division of General Internal Medicine, University of PittsburghDepartment of Emergency Medicine, University of PittsburghAbstract 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.http://link.springer.com/article/10.1186/s12873-017-0138-1ProcalcitoninBiomarkersRespiratory tract infectionsClinical trialAnti-bacterial agentsMethods (MeSH) |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
David T. Huang Derek C. Angus Chung-Chou H. Chang Yohei Doi Michael J. Fine John A. Kellum Octavia M. Peck-Palmer Francis Pike Lisa A. Weissfeld Jonathan Yabes Donald M. Yealy on behalf of the ProACT Investigators |
spellingShingle |
David T. Huang Derek C. Angus Chung-Chou H. Chang Yohei Doi Michael J. Fine John A. Kellum Octavia M. Peck-Palmer Francis Pike Lisa A. Weissfeld Jonathan Yabes Donald M. Yealy on behalf of the ProACT Investigators 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 Procalcitonin Biomarkers Respiratory tract infections Clinical trial Anti-bacterial agents Methods (MeSH) |
author_facet |
David T. Huang Derek C. Angus Chung-Chou H. Chang Yohei Doi Michael J. Fine John A. Kellum Octavia M. Peck-Palmer Francis Pike Lisa A. Weissfeld Jonathan Yabes Donald M. Yealy on behalf of the ProACT Investigators |
author_sort |
David T. Huang |
title |
Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection |
title_short |
Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection |
title_full |
Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection |
title_fullStr |
Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection |
title_full_unstemmed |
Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection |
title_sort |
design and rationale of the procalcitonin antibiotic consensus trial (proact), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection |
publisher |
BMC |
series |
BMC Emergency Medicine |
issn |
1471-227X |
publishDate |
2017-08-01 |
description |
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. |
topic |
Procalcitonin Biomarkers Respiratory tract infections Clinical trial Anti-bacterial agents Methods (MeSH) |
url |
http://link.springer.com/article/10.1186/s12873-017-0138-1 |
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