Figures
- Figure 1–
Percentage of sputum samples with an identified pathogen according to sputum colour. Data in the bars are presented as n/N.
- Figure 2–
Distribution of sputum colour by infecting species. a) Haemophilus influenzae, b) Streptococcus pneumoniae, c) Moraxella catarrhalis, d) Haemophilus parainfluenzae, e) Staphylococcus aureus, f) Klebsiella pneumoniae, g) Pseudomonas aeruginosa and h) Haemophilus spp.
Tables
- Table 1 Designs of the six studies included in the sputum analysis
Study number [ref.] Design Treatment (moxifloxacin and comparator)# Patients n Patients with a causative organism n 84 [6] Prospective, multicentre, multinational, nonblind, randomised study in Europe Moxifloxacin, 400 mg q.d. for 5 days; amoxicillin/clavulanate, 625 mg t.i.d. for 7 days 575 251 100033 [7] Prospective, randomised, double-blind, multicentre study in the USA Moxifloxacin, 400 mg q.d. for 5 days; moxifloxacin, 400 mg q.d. for 10 days; clarithromycin, 500 mg b.i.d. for 10 days 926 491 100034¶ Prospective, randomised, double-blind, multicentre study in the USA and Canada Moxifloxacin, 400 mg q.d. for 10 days; moxifloxacin, 200 mg q.d. for 10 days; cefuroxime axetil, 500 mg b.i.d. for 10 days 682 274 100160 [8] Prospective, randomised, double-blind, multicentre study in the USA and Canada Moxifloxacin, 400 mg q.d. for 5 days; azithromycin, 250 mg q.d. (500 mg on day 1) for 5 days 567 280 100243 [9] Prospective, randomised, double-blind, multicentre study in the USA Moxifloxacin, 400 mg q.d. for 5 days; levofloxacin, 500 mg q.d. for 7 days 594 315 240017 [10] Prospective, randomised, double-blind, multicentre study in Europe Moxifloxacin, 400 mg q.d. for 5 days; clarithromycin, 500 mg b.i.d. for 7 days 745 287 #: all treatments were administered orally; ¶: data held on file by Bayer Schering Pharma.
- Table 2– Demographics of patients included in the sputum analysis
Characteristic All patients PPM positive PPM negative p-value# Subjects n 4089 1898 2191 Male sex % 55.0 61.0 49.8 <0.001 Age yrs 56±15.3 55.3±15.5 57.2±15.0 <0.001 Exacerbations in previous year¶ 2.5±1.9 2.4±1.6 2.5±2.1 0.614 Median (IQR) duration of exacerbation before study entry days 2 (5) 2 (5) 2 (6) 0.130 Past or present smoker¶ 3280 (80.2) 1629 (85.8) 1651 (75.4) <0.001 Use of long-term bronchodilators or steroids 261 (6.4) 116 (6.1) 147 (6.7) 0.135 Median (IQR) CRP level¶ mg·L−1 0.70 (1.79) 0.69 (2.17) 0.71 (1.56) 0.551 Fever present 744 (18.2) 294 (15.5) 389 (20.5) 0.005 Data are presented as mean±sd or n (%), unless otherwise stated. PPM: potentially pathogenic microorganism; IQR: interquartile range; CRP: C-reactive protein. #: PPM positive versus PPM negative; ¶: data were not collected for all patients in the study for these characteristics. Cochrane–Mantel–Haenszel test, adjusting for study, categorical variables, and using an ANOVA, also adjusting for study, for the continuous variables.
- Table 3– Commonly isolated potentially pathogenic microorganisms: number overall and proportion by sputum colour
Microorganism Total isolates n Samples containing specific pathogen# % Yellow sputum Green sputum White sputum Rust sputum Samples of each colour¶ n 2319 1218 353 113 Haemophilus influenzae 605 14.1 20.0 10.6 5.9 Streptococcus pneumoniae 313 7.4 9.5 12.4 2.5 Moraxella catarrhalis 319 7.3 11.2 2.3 4.4 Haemophilus parainfluenzae 262 5.8 9.2 2.5 5.3 Staphylococcus aureus 158 3.4 5.4 1.7 5.3 Klebsiella pneumoniae 133 3.9 3.1 0.8 1.8 Pseudomonas aeruginosa 105 2.4 3.1 2.5 1.8 Haemophilus spp.+ 64 1.4 2.4 0.3 0.0 Negative culture§ 2191 54.5 41.1 81.6 61.1 #: percentage of isolates of each species based on the total number of culture samples; ¶: one sample obtained per patient; +: Haemophilus spp. other than H. influenzae and H. parainfluenzae; §: total number of negative cultures.
- Table 4– Performance parameters of the colour of sputum in the diagnosis of the presence of a potential pathogenic microorganism by study
Study number [ref.] Sensitivity % Specificity % PPV % NPV % PLR NLR 84 [6] 96.8 (93.8–98.6) 4.6 (2.6–7.6) 44.1 (39.3–48.4) 65.2 (42.7–83.6) 1.02 (0.98–1.05) 0.68 (0.30–1.59) 100033 [7] 91.8 (88.9–94.0) 19.2 (15.6–23.3) 56.6 (53.1–60.1) 66.9 (57.8–75.2) 1.14 (1.08–1.20) 0.43 (0.30–0.61) 100034# 95.3 (92.0–97.5) 24.4 (20.2–29.0) 47.0 (42.8–51.3) 88.0 (80.3–93.4) 1.26 (1.18–1.34) 0.19, (0.11–0.34) 100160 [8] 96.8 (93.9–98.5) 16.5 (12.3–21.5) 54.1 (49.6–58.6) 83.3 (97.7–92.10 1.16 (1.09–1.23) 0.20 (0.10–0.39) 100243 [9] 95.6 (92.7–97.6) 13.6 (9.7–18.2) 56.1 (51.7–60.3) 72.6 (58.3–84.1) 1.11 (1.05–1.17) 0.33 (0.18–0.59) 240017 [10] 91.1 (87.2–94.2) 18.9 (15.4–22.9) 41.6 (37.6–45.6) 77.1 (68.0–84.6) 1.12 (1.06–1.19) 0.47 (0.31–0.72) Pooled 94.8 (92.1–97.4) 15.0 (6.7–23.3) NC NC NC NC PPV: positive predictive value; NPV: negative predictive value; PLR: positive likelihood ratio; NLR: negative likelihood ratio; NC: not calculated. #: data held on file by Bayer Schering Pharma.
- Table 5– Regression analysis of significant factors predicting the presence of potentially pathogenic microorganisms in sputum
Variable Wald Chi-squared p-value OR point estimate (95% CI) Sputum colour 108.4 <0.001 Yellow versus white 3.2 (2.3–4.2) Green versus white 4.9 (3.6–6.8) Rust versus white 2.3 (1.4–3.7) Study 32.7 <0.001 84 versus 240017 [6, 10] 1.0 (0.8–1.3) 100033 versus 240017 [7, 10] 1.6 (1.3–2.0) 100034# versus 240017 [10] 1.1 (0.8–1.3) 100160 versus 240017 [8, 10] 1.3 (1.0–1.6) 100243 versus 240017 [9, 10] 1.4 (1.1–1.9) Sputum aspect 27.0 <0.001 Purulent versus mucoid 2.0 (1.6–2.5) Purulent versus mucopurulent 1.1 (1.0–1.2) Dyspnoea 6.6 0.036 Increased versus not increased 1.27 (1.1–1.5) Sex 40.7 <0.001 Male versus female 1.5 (1.3–1.8) Fever 14.8 0.001 Absent versus present 1.3 (1.1–1.6) #: data held on file by Bayer Schering Pharma.
