Randomized Controlled Trial

. 2017 Aug 29;17(1):25.

doi: 10.1186/s12873-017-0138-1.

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

David T Huang^{1

2

3

4}, Derek C Angus^{5

6

7}, Chung-Chou H Chang^{5

8}, Yohei Doi⁹, Michael J Fine^{8

10}, John A Kellum^{5

6}, Octavia M Peck-Palmer^{5

11}, Francis Pike¹², Lisa A Weissfeld¹³, Jonathan Yabes⁸, Donald M Yealy^{14

7}; ProACT Investigators

Collaborators, Affiliations

Collaborators

Affiliations

¹ The CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) Center, Pittsburgh, PA, USA. huangdt@upmc.edu.
² Department of Critical Care Medicine, University of Pittsburgh, Room 606B Scaife Hall, 3550 Terrace Street, Pittsburgh, PA, 15261, USA. huangdt@upmc.edu.
³ Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA. huangdt@upmc.edu.
⁴ The MACRO (Multidisciplinary Acute Care Research Organization) Center, Pittsburgh, PA, USA. huangdt@upmc.edu.
⁵ The CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) Center, Pittsburgh, PA, USA.
⁶ Department of Critical Care Medicine, University of Pittsburgh, Room 606B Scaife Hall, 3550 Terrace Street, Pittsburgh, PA, 15261, USA.
⁷ The MACRO (Multidisciplinary Acute Care Research Organization) Center, Pittsburgh, PA, USA.
⁸ Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
⁹ Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, PA, USA.
¹⁰ Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.
¹¹ Department of Pathology, University of Pittsburgh, Pittsburgh, PA, USA.
¹² Eli Lilly and Company, Indianapolis, IN, USA.
¹³ Statistics Collaborative, Inc., Washington, DC, USA.
¹⁴ Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA.

PMID: 28851296
PMCID: PMC5576372
DOI: 10.1186/s12873-017-0138-1

Randomized Controlled Trial

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

David T Huang et al. BMC Emerg Med. 2017.

. 2017 Aug 29;17(1):25.

doi: 10.1186/s12873-017-0138-1.

Authors

Collaborators

Affiliations

¹ The CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) Center, Pittsburgh, PA, USA. huangdt@upmc.edu.
² Department of Critical Care Medicine, University of Pittsburgh, Room 606B Scaife Hall, 3550 Terrace Street, Pittsburgh, PA, 15261, USA. huangdt@upmc.edu.
³ Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA. huangdt@upmc.edu.
⁴ The MACRO (Multidisciplinary Acute Care Research Organization) Center, Pittsburgh, PA, USA. huangdt@upmc.edu.
⁵ The CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) Center, Pittsburgh, PA, USA.
⁶ Department of Critical Care Medicine, University of Pittsburgh, Room 606B Scaife Hall, 3550 Terrace Street, Pittsburgh, PA, 15261, USA.
⁷ The MACRO (Multidisciplinary Acute Care Research Organization) Center, Pittsburgh, PA, USA.
⁸ Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
⁹ Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, PA, USA.
¹⁰ Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.
¹¹ Department of Pathology, University of Pittsburgh, Pittsburgh, PA, USA.
¹² Eli Lilly and Company, Indianapolis, IN, USA.
¹³ Statistics Collaborative, Inc., Washington, DC, USA.
¹⁴ Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA.

PMID: 28851296
PMCID: PMC5576372
DOI: 10.1186/s12873-017-0138-1

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.

Keywords: Anti-bacterial agents; Biomarkers; Clinical trial; Methods (MeSH); Procalcitonin; Respiratory tract infections.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

The University of Pittsburgh Institutional Review Board approved the ProACT trial.

Consent for publication

Not applicable.

Competing interests

David T. Huang receives grant funding from ThermoFisher for a study examining the microbiome in lower respiratory tract infection.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

**Fig. 1**
ProACT guidelines. The ProACT Coordinating Center provided posters of this Figure to all centers. Other study education, in-service training, and promotion materials contain the same content

See this image and copyright information in PMC

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Ethics approval and consent to participate

Consent for publication

Competing interests

Publisher’s Note

Figures

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Cited by

References

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Abstract

Conflict of interest statement

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Consent for publication

Competing interests

Publisher’s Note

Figures

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