Chest
Volume 144, Issue 5, November 2013, Pages 1571-1577
Journal home page for Chest

Original Research
COPD
Is It Possible to Identify Exacerbations of Mild to Moderate COPD That Do Not Require Antibiotic Treatment?

https://doi.org/10.1378/chest.13-0518Get rights and content

Background

Anthonisen criteria are widely used to guide the use of antibiotics in exacerbations of COPD. We evaluated the best predictors of outcomes in exacerbations of mild to moderate COPD not treated with antibiotics.

Methods

We used data from 152 patients of the placebo arm of a randomized trial of amoxicillin/clavulanate for exacerbations of mild to moderate COPD. Clinical response in relation to Anthonisen criteria and point-of-care serum C-reactive protein (CRP) tests (cutoff, 40 mg/L) was assessed with multivariate logistic regression analysis.

Results

Clinical failure without antibiotics was 19.9% compared with 9.5% with amoxicillin/clavulanate (P = .022). The only factors significantly associated with an increased risk of failure without antibiotics were the increase in sputum purulence (OR, 6.1; 95% CI, 1.5–25.0; P = .005) and a CRP concentration ≥ 40 mg/L (OR, 13.4; 95% CI, 4.6–38.8; P < .001). When both factors were present, the probability of failure without antibiotics was 63.7%. The Anthonisen criteria showed an area under the curve of 0.708 (95% CI, 0.616–0.801) for predicting clinical outcome. With the addition of CRP level, the area under the curve rose significantly to 0.842 (95% CI, 0.76–0.924; P < .001).

Conclusions

Among the Anthonisen criteria, only an increase in sputum purulence is a significant predictor of failure without antibiotics. The use of a point-of-care CRP test significantly increases the predictive accuracy of failure. Both of these easy-to-obtain factors may help clinicians to identify patients with exacerbated mild to moderate COPD who can be safely treated without antibiotics in an ambulatory setting.

Trial registry

ClinicalTrials.gov; No.: NCT00495586; URL: www.clinicaltrials.gov

Section snippets

Materials and Methods

The methods, design, and outcomes of this trial have been previously described in detail.8 In short, 310 patients with exacerbations of mild to moderate COPD were enrolled from primary care between October 2007 and July 2010 into a multicenter, double-blind, randomized placebo-controlled trial that investigated the efficacy of amoxicillin/clavulanate 500/125 mg tid for 8 days. To investigate the predictors of failure without antibiotics, we analyzed data derived from the 152 patients included

Baseline Characteristics

In the original randomized trial, 310 patients were enrolled. The placebo group of this trial, comprising 152 patients, was used for the current study. Table 1 shows the baseline characteristics of the population treated with placebo according to the type of exacerbation.1 The mean ± SD age of the patients in the placebo group was 67.8 ± 11 years, and 78.3% were men. The mean FEV1 was 65.9 ± 12.1% predicted, and most patients had either a type 2 (47.4%) or a type 1 (29.6%) exacerbation. The

Discussion

The analysis of the placebo arm results of a randomized, double-blind, antibiotic trial in exacerbated mild to moderate COPD provided a unique opportunity to investigate the factors associated with clinical outcomes and to identify patients who can be safely treated without antibiotics in an ambulatory setting.8 We revisited the classic Anthonisen criteria for antibiotic treatment1 and demonstrated that only an increase in sputum purulence was associated with a significant increase in the risk

Acknowledgments

Author contributions: Dr Miravitlles had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Dr Miravitlles: contributed to the study design, participant recruitment and follow-up, and drafting and review of the manuscript.

Dr Moragas: contributed to the study design, trial coordination, and review of the manuscript.

Dr Hernández: contributed to the participant recruitment and follow-up and revision and approval

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    Funding/Support: This clinical trial was supported by a grant from the Instituto de Salud Carlos III (Spanish Ministry of Health) (EC07/90333).

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