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      Antibiotic Treatment of Severe Exacerbations of Chronic Obstructive Pulmonary Disease with Procalcitonin: A Randomized Noninferiority Trial

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          Abstract

          Background

          The duration of antibiotic treatment of exacerbations of COPD (ECOPD) is controversial. Serum procalcitonin (PCT) is a biomarker of bacterial infection used to identify the cause of ECOPD.

          Methods and Findings

          We investigated whether a PCT-guided plan would allow a shorter duration of antibiotic treatment in patients with severe ECOPD. For this multicenter, randomized, non-inferiority trial, we enrolled 184 patients hospitalized with ECOPD from 18 hospitals in Italy. Patients were assigned to receive antibiotics for 10 days (standard group) or for either 3 or 10 days (PCT group). The primary outcome was the rate of ECOPD at 6 months. Having planned to recruit 400 patients, we randomized only 183: 93 in the PCT group and 90 in the standard group. Thus, the completed study was underpowered. The ECOPD rate at 6 months between PCT-guided and standard antibiotic treatment was not significant (% difference, 4.04; 90% confidence interval [CI], −7.23 to 15.31), but the CI included the non-inferiority margin of 15. In the PCT-guided group, about 50% of patients were treated for 3 days, and there was no difference in primary or secondary outcomes compared to patients treated for 10 days.

          Conclusions

          Although the primary and secondary clinical outcomes were no different for patients treated for 3 or 10 days in the PCT group, the conclusion that antibiotics can be safely stopped after 3 days in patients with low serum PCT cannot be substantiated statistically. Thus, the results of this study are inconclusive regarding the noninferiority of the PCT-guided plan compared to the standard antibiotic treatment. The study was funded by Agenzia Italiana del Farmaco (AIFA-FARM58J2XH). Clinical trial registered with www.clinicaltrials.gov (NCT01125098).

          Trial Registration

          ClinicalTrials.gov NCT01125098

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          Most cited references 19

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          New strains of bacteria and exacerbations of chronic obstructive pulmonary disease.

          The role of bacterial pathogens in acute exacerbations of chronic obstructive pulmonary disease is controversial. In older studies, the rates of isolation of bacterial pathogens from sputum were the same during acute exacerbations and during stable disease. However, these studies did not differentiate among strains within a bacterial species and therefore could not detect changes in strains over time. We hypothesized that the acquisition of a new strain of a pathogenic bacterial species is associated with exacerbation of chronic obstructive pulmonary disease. We conducted a prospective study in which clinical information and sputum samples for culture were collected monthly and during exacerbations from 81 outpatients with chronic obstructive pulmonary disease. Molecular typing of sputum isolates of nonencapsulated Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae, and Pseudomonas aeruginosa was performed. Over a period of 56 months, the 81 patients made a total of 1975 clinic visits, 374 of which were made during exacerbations (mean, 2.1 per patient per year). On the basis of molecular typing, an exacerbation was diagnosed at 33.0 percent of the clinic visits that involved isolation of a new strain of a bacterial pathogen, as compared with 15.4 percent of visits at which no new strain was isolated (P<0.001; relative risk of an exacerbation, 2.15; 95 percent confidence interval, 1.83 to 2.53). Isolation of a new strain of H. influenzae, M. catarrhalis, or S. pneumoniae was associated with a significantly increased risk of an exacerbation. The association between an exacerbation and the isolation of a new strain of a bacterial pathogen supports the causative role of bacteria in exacerbations of chronic obstructive pulmonary disease. Copyright 2002 Massachusetts Medical Society
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            The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes.

            To improve the clinical measurement of dyspnea, we developed a baseline dyspnea index that rated the severity of dyspnea at a single state and a transition dyspnea index that denoted changes from that baseline. The scores in both indexes depend on ratings for three different categories: functional impairment; magnitude of task, and magnitude of effort. At the baseline state, dyspnea was rated in five grades from 0 (severe) to 4 (unimpaired) for each category. The ratings for each of the three categories were added to form a baseline focal score (range, 0 to 12). At the transition period, changes in dyspnea were rated by seven grades, ranging from -3 (major deterioration), to +3 (major improvement). The ratings for each of the three categories were added to form a transition focal score (range, -9 to +9). In 38 patients tested with respiratory disease, interobserver agreement was highly satisfactory for both indexes. The baseline focal score had the highest correlation (r = 0.60; P less than 0.001) with the 12-minute walking distance (12 MW), while significant, but lower, correlations existed for lung function. For the transition focal score, there was a significant correlation only with the 12 MW (r = 0.33; p = 0.04). These results indicate that dyspnea can receive a direct clinical rating that provides important information not disclosed by customary physiologic tests.
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              COPD exacerbations .1: Epidemiology.

              The epidemiology of exacerbations of chronic obstructive pulmonary disease (COPD) is reviewed with particular reference to the definition, frequency, time course, natural history and seasonality, and their relationship with decline in lung function, disease severity and mortality. The importance of distinguishing between recurrent and relapsed exacerbations is discussed.
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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                11 March 2015
                2015
                : 10
                : 3
                Affiliations
                [1 ]Department of Oncology, Haematology and Respiratory Diseases, University of Modena & Reggio Emilia, Modena, Italy
                [2 ]Statistics Unit, Department of Diagnostic and Clinical Medicine and Public Health, University of Modena & Reggio Emilia, Modena, Italy
                [3 ]Department of Laboratory Medicine, University of Padova, Padova, Italy
                [4 ]Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy
                [5 ]Department of Clinical and Experimental Medicine, Division of Pulmonary Rehabilitation, Fondazione S. Maugeri (Tradate), University of Insubria, Varese, Italy
                [6 ]Department of Respiratory & Allergic Diseases, University of Genova, Genova, Italy
                [7 ]Department of Respiratory Diseases, University of Ferrara, Ferrara, Italy
                The National Institute for Health Innovation, NEW ZEALAND
                Author notes

                Competing Interests: LMF received payment for consultancy from: Almirall, Boehringer LMF received payment for consultancy from: Almirall, Boehringer Ingelheim, Chiesi Farmaceutici, Euromediform, GlaxoSmithKline, Merck Sharp & Dhome, Mundipharma International, Novartis, Takeda, Pearl Therapeutics, Sterna, Peer Voice Europe, OM Pharma, TEVA; payment for lectures, advisory boards or travel expenses reimbursements from: AstraZeneca, Dey Pharma, Grünenthal GmbH, Mundipharma International, Novartis, Roche, Genetech Inc. AS declares he received personal benefits or personal travel grants or expenses for conferences from Boehringer, Novartis, Astrazeneca, Guidotti, Malesci, Almirall, Gsk, Mundipharma, Pfizer. AP gave presentations at symposia sponsored by, received research grants from, or served on scientific advisory boards of Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Dompè, GlaxoSmithKline, Guidotti, Menarini, MSD, Mundipharma, Novartis, Pfizer, Takeda, TEVA, Zambon. SB, VR, RV, MPFB, GWC, MP, FL, BB, AV, AL, RDA declare they have no conflicts. This does not alter the authors’ adherence to PLOS ONE policies on sharing data and materials.

                Conceived and designed the experiments: AV FL RDA AP LMF BB. Performed the experiments: AL MP. Analyzed the data: RDA RV SB. Contributed reagents/materials/analysis tools: RV VR. Wrote the paper: AV FL RDA AP LMF BB.

                ¶ Membership of the FARM58J2XH Study Group is provided in the Acknowledgments.

                Article
                PONE-D-14-29964
                10.1371/journal.pone.0118241
                4356612
                25760346

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

                Page count
                Figures: 3, Tables: 5, Pages: 16
                Product
                Funding
                This research was supported by Agenzia Italiana del Farmaco (AIFA, Roma, Italy) (AIFA-FARM58J2XH); Consorzio Ferrara Ricerche (CFR, Ferrara, Italy); and Fondazione Chiesi, Parma, Italy. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Custom metadata
                All relevant data are within the paper and its Supporting Information files. The protocol is available at the following website: http://servertrial.unimore.it/proct/.

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