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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| Vydáno v: | BMC emergency medicine Ročník 17; číslo 1; s. 25 - 10 |
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| Hlavní autoři: | , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
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London
BioMed Central
29.08.2017
BioMed Central Ltd Springer Nature B.V BMC |
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| ISSN: | 1471-227X, 1471-227X |
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| 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. |
|---|---|
| AbstractList | 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. 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. 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. 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.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.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.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.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.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.ClinicalTrials.gov NCT02130986 . Registered May 1, 2014.TRIAL REGISTRATIONClinicalTrials.gov NCT02130986 . Registered May 1, 2014. 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. |
| ArticleNumber | 25 |
| Audience | Academic |
| Author | Fine, Michael J. Angus, Derek C. Pike, Francis Yabes, Jonathan Doi, Yohei Chang, Chung-Chou H. Weissfeld, Lisa A. Huang, David T. Kellum, John A. Yealy, Donald M. Peck-Palmer, Octavia M. |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/28851296$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_3166_afmu_2019_0182 crossref_primary_10_1373_jalm_2018_028449 crossref_primary_10_1007_s11936_019_0738_z crossref_primary_10_1093_jalm_jfae114 crossref_primary_10_1177_0018578718762128 crossref_primary_10_1056_NEJMoa1802670 crossref_primary_10_1093_ofid_ofy327 |
| Cites_doi | 10.1001/jama.2009.1297 10.1016/S0140-6736(09)61879-1 10.7326/0003-4819-143-12-200512200-00006 10.7326/0003-4819-148-4-200802190-00008 10.1371/journal.pmed.1000111 10.1164/rccm.200512-1922OC 10.1378/chest.06-1500 10.1016/j.annemergmed.2012.02.033 10.1016/j.annemergmed.2008.01.003 10.7326/M15-1840 10.1016/S0140-6736(04)15591-8 10.1016/S0140-6736(10)60140-7 10.1086/511159 10.1016/j.annemergmed.2003.09.013 10.1371/journal.pmed.1000251 10.1093/jac/dkt301 10.1001/jamainternmed.2016.3646 10.1016/0140-6736(93)90277-N 10.1086/421997 10.1164/rccm.200406-746OC 10.1001/jama.2012.87802 10.1001/jama.294.17.2203 10.1016/j.annemergmed.2007.03.022 10.1001/jama.2012.476 10.1001/jama.2016.11764 10.1016/j.clinbiochem.2009.08.029 10.1001/jama.2016.4151 10.1001/jama.293.24.3029 10.1186/1472-6963-7-102 10.1159/000339789 10.1309/AJCP1MFYINQLECV2 10.1016/S0954-6111(98)90423-1 10.1001/jama.2010.796 10.1001/jama.2014.12923 10.1186/1471-2334-7-10 10.1056/NEJMp1408040 10.1046/j.1469-0691.2002.00406.x 10.1016/j.jaci.2007.09.029 10.1097/MLR.0b013e31819261bd 10.1016/j.annemergmed.2012.05.014 10.1093/infdis/jiv252 10.1001/jama.2009.1318 |
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| Contributor | Prunty, Heather Sherwin, Robert Dachman, William Hammel, Jean Kurz, Michael Filbin, Michael Southerland, Lauren Exline, Matthew Lotfipour, Shahram Hou, Peter Fine, Jonathan LoVecchio, Frank Rodgers, Daniel Wilkerson, Gentry McCullum, David Jovin, Franziska Donnino, Michael Holst, John Rafferty, Colleen Brown, Aaron Suffoletto, Brian |
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| Copyright | The Author(s). 2017 COPYRIGHT 2017 BioMed Central Ltd. Copyright BioMed Central 2017 |
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| Keywords | Respiratory tract infections Biomarkers Clinical trial Methods (MeSH) Anti-bacterial agents Procalcitonin |
| Language | English |
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Overuse of antibiotics is a major public health problem, contributing to growing antibiotic resistance. Procalcitonin has been reported to be... Overuse of antibiotics is a major public health problem, contributing to growing antibiotic resistance. Procalcitonin has been reported to be commonly elevated... Background Overuse of antibiotics is a major public health problem, contributing to growing antibiotic resistance. Procalcitonin has been reported to be... Abstract Background Overuse of antibiotics is a major public health problem, contributing to growing antibiotic resistance. Procalcitonin has been reported to... |
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| SubjectTerms | 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 |
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| Title | Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection |
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