COPD: ceftibuten was as effective as amoxicillin-clavulanate for curing acute exacerbations

Clinical bottom line (level 1b)

  1. Patients with acute exacerbations of chronic bronchitis who received ceftibuten compared with amoxicillin-clavulanate were as likely to be cured and not clearly more likely to have adverse side-effects.
McAdoo et al: Clinical Therapeutics 1998; 20 (1): 88-100
Expires November 2002

The study

Single-blinded ?concealed randomised trial with intention-to-treat
Setting: 32 acute hospitals, USA

469 patients (aged range 18 to 84 years, ?% male) with an acute exacerbation of chronic bronchitis (persistent cough and sputum production for 2 consecutive years and on most days for 3 consecutive months). Exacerbations were defined as increased cough or dyspnoea with increased sputum production and purulence suggestive of bacterial infection.

Excluded if
  • aged < 18
  • patients at high risk of dying within 48 hours
  • chronic diarrhoea
  • pregnant or nursing women
  • presence of infection at enrolment known to be resistant to study drugs
  • renal or hepatic dysfunction
  • neutropenia
  • history of hypersensitivity to beta-lactam antibiotics
  • presence of immunodeficiency or malignant disease
  • increase in or initiation of corticosteroid treatment during study
  • treatment with another investigational drug within previous 30 days
  • treatment with another antibiotic within previous 72 hours


    • Control Group: (n = 153, 153 analysed): amoxicillin-clavulanate 500 mg three times a day by mouth for 5 to 15 days
    Experimental Group: (n = 316, 316 analysed): ceftibuten 400 mg once daily by mouth for 5 to 15 days

    100% followed for 21 days

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    clinical failure 21 days 42
    (27.5%)    		 74
    (23.4%)    		 15%
    (-18% to 38%)    		 4.03%
    (-4.44% to 12.5%)    		 25
    (NNT = 8 to infinity;
    NNH = 23 to infinity)
    adverse effects 21 days 46
    (30.1%)    		 71
    (22.5%)    		 25%
    (-3% to 46%)    		 7.60%
    (-1.00% to 16.2%)    		 13
    (NNT = 6 to infinity;
    NNH = 100 to infinity)

    Citation

    1. McAdoo MA, Rice K, Gordon GR, et al: comparison of ceftibuten once daily and amoxicillin-clavulanate three times daily in the treatment of acute exacerbations of chronic bronchitis. Clinical Therapeutics 1998; 20 (1): 88-100
    Search Terms: ?
    Contributor: Chris Ball and Clare Wotton, November 1999
    Reviewer: Mitsuhiro Kamei

    Clinical Question.
    Patient acute exacerbation of COPD
    Intervention or Exposure ceftibuten
    Comparison amoxicillin-clavulanate
    Outcome clinical success, side-effects