COPD: ciprofloxacin was not clearly different from clarithromycin.

Clinical bottom line (level 1b-)

  1. Patients who had an acute exacerbation of chronic bronchitis and were given ciprofloxacin had no clear difference in clinical success than those given clarithromycin.
  2. Patients given ciprofloxacin had no clear difference in relapse of infection at 5 weeks than those given clarithromycin.
Anzueto et al: Clinical Therapeutics 1997; 19: 989-1001
Expires November 2003

The study

?blinded ?concealed randomised trial with intention-to-treat
Setting: multicentre community-based, USA

743 patients (aged mean 62 years, 51% female) Primary diagnosis of chronic bronchitis or COPD as defined by the American Thoracic Society with severe or complicated acute exacerbation. With one or more of: failed previous antibiotic treatment for exacerbation, likelihood of resistant pathogen, at least three exacerbations in the last year or at least three co morbid conditions

Excluded if
  • <40 years old
  • clinical or microbiologic evidence of pneumonia
  • evidence of new bronchopulmonary infiltrate or lobar consolidation on chest radiograph
  • recently diagnosed or unresolved lung or chest-cavity malignancy, AIDS, active pulmonary tuberculosis, cystic fibrosis or symptomatic bronchiectasis
  • need for concomitant antibiotic agents having a similar spectrum of activity to study drug
  • allergy to carboxyquinolones or macrolide derivatives
  • previous enrolment in this study
  • pregnancy or lactation
  • baseline serum creatinine level = 3.0 mg/dL
  • Gram's stain sputum smears had >10 squamous epithelial cells and <25 leukocytes per low-power field
  • bacterial numbers during exacerbation no > than when stable


    • Control Group: (n = 374, 321 analysed): clarithromycin one 500 mg tablet twice daily for 10 days
    Experimental Group: (n = 369, 314 analysed): ciprofloxacin one 750 mg tablet twice daily for 10 days

    99% followed for 5 weeks
    Outcome notes:
    • clinical success : resolution - disappearance of acute signs and symptoms, with complete return to a stable pre-exacerbation condition in chronic bronchitis such that additional antibiotic treatment was not necessary; or improvement - reduction in severity and/ or number of signs and symptoms of infection, but further antibiotic therapy still required
    • relapse : recurrence or re-infection

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    clinical success 10 days 281
    (87.5%)    		 283
    (90.1%)    		 21%
    (-23% to 49%)    		 2.59%
    (-2.30% to 7.8%)    		 39
    (NNT = 43 to infinity;
    NNH = 13 to infinity)
    relapse 5 weeks 24
    (7.48%)    		 22
    (7.01%)    		 6.00%
    (-64.0% to 46.0%)    		 0.47%
    (-3.56% to 4.50%)    		 213
    (NNT = 22 to infinity;
    NNH = 28 to infinity)

  • There was no difference in occurrence of adverse effects.

    • Comments

    1. The trial is too small to show any clear difference in clinical success or relapse between the two drugs.

    Citation

    1. Anzueto A, Niederman MS, Haverstock DC, et al: Efficacy of ciprofloxacin and clarithromycin in acute bacterial exacerbation of complicated chronic bronchitis: Interim analysis. Clinical Therapeutics 1997; 19: 989-1001
    Search Terms: chronic bronchitis and therapy in Medline
    Contributor: Clare Wotton and Musab Hayatli, November 1999
    Reviewer: Santiago Alvarez Montero

    Clinical Question.
    Patient acute exacerbation of chronic bronchitis
    Intervention or Exposure ciprofloxacin
    Comparison clarithromycin
    Outcome clinical success