Guideline-Based Clinical Assessment Versus Procalcitonin-Guided Antibiotic Use in Pneumonia: A Pragmatic Randomized Trial - 19/09/19
, François Javaudin, MD, MSc a, Farès Moustafa, MD, PhD b, Demeno Nandjou, MD c, Maxime Maignan, MD, PhD d, Jean-Benoit Hardouin, PhD e, Caroline Annoot, MD f, Maja Ogielska, MD g, Pascal-Louis Orer, MD h, Thibault Schotté, MD i, Jacques Bouget, MD, PhD j, Syamak Agha Babaei, MD k, Pierre-Alexis Raynal, MD l, Antoine Eche, MD m, Albert Trinh Duc, MD, PhD c, Ruxandra-Aimée Cojocaru, MD k, Nesrine Benaouicha, MD a, Gilles Potel, MD, PhD a, Eric Batard, MD, PhD a, David A. Talan, MD n, o, ⁎ Abstract |
Study objective |
Efforts to reduce unnecessary and unnecessarily long antibiotic treatment for community-acquired pneumonia have been attempted through use of procalcitonin and through guidelines based on serial clinical assessment. Our aim is to compare guideline-based clinical assessment– and procalcitonin algorithm–guided antibiotic use among patients with community-acquired pneumonia.
Methods |
We performed a pragmatic, randomized, multicenter trial from November 2012 to April 2015 at 12 French hospitals. We included emergency department (ED) patients older than 18 years with community-acquired pneumonia. Patients were randomly assigned to either the procalcitonin-guided or clinical assessment group. In accordance with past studies, we hypothesized that serial clinical assessment would be superior to procalcitonin-guided care. The primary outcome was antibiotic duration, and secondary outcomes included rates of antibiotic duration less than or equal to 5 days, and clinical success and combined serious adverse outcomes at 30 days in the intention-to-treat population.
Results |
Of 370 eligible patients, 285 (77%) were randomly assigned to either clinical assessment– (n=143) or procalcitonin-guided care (n=142). Median age was 67 years (range 18 to 93 years) and 40% of patients were deemed to have Pneumonia Severity Index class IV or V. Procalcitonin algorithm adherence was 76%. Antibiotic duration was not significantly different between clinical assessment– and procalcitonin-guided groups (median 9 versus 10 days, respectively). Clinical success rate was 92% in each group and serious adverse outcome rates were similar (15% versus 20%, respectively).
Conclusion |
Guideline-based serial clinical assessment did not reduce antibiotic exposure compared with procalcitonin-guided care among ED patients with community-acquired pneumonia. The strategies were similar in terms of duration of antibiotic use and clinical outcomes.
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| Please see page 581 for the Editor’s Capsule Summary of this article. |
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| Supervising editor: Donald M. Yealy, MD. Specific detailed information about possible conflict of interest for individual editors is available at editors. |
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| Dr. Schotté is now affiliated with the Department of Emergency Medicine, Centre Hospitalier Le Mans, Le Mans, France. Dr. Eche is now affiliated with the Department of Emergency Medicine, Centre Hospitalier Aix-en-Provence, Aix-en-Provence, France |
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| Author contributions: EM had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. EM, GP, EB, and DAT conceived and designed the study. FJ, FM, DN, MM, JBH, CA, MO, PLO, TS, JB, SAB, PAR, AE, ATD, NB, and RC acquired, analyzed, and interpreted the data. EM drafted the article. EB and DAT made critical revisions to the article for important intellectual content. EM takes responsibility for the paper as a whole. |
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| All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. |
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| Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist. The study was supported by a grant from the French Ministry of Health (PHRC API12/N/080). |
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| Trial registration number: NCT01723644 |
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Vol 74 - N° 4
P. 580-591 - ottobre 2019 Ritorno al numero
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