COPD: sparfloxacin was not clearly different to co-amoxiclav.

Clinical bottom line (level 1b-)

  1. Patients who have had an acute exacerbation of chronic bronchitis and were given sparfloxacin, had no clear difference in clinical success than those given co-amoxiclav.
  2. Patients who were given sparfloxacin had no clear difference in adverse effects than those given co-amoxiclav.
Allegra et al: Journal of Antimicrobial Chemotherapy 1996; 37 (Suppl.A): 93-104
Expires May 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: multicentre, Italy, Germany, France, UK and Belgium

733 patients (aged mean 61 years, 67% male) History of chronic bronchitis (sputum-productive cough for at least 3 months of the year for at least the previous 2 years, emphysema or asthma) with symptoms of acute exacerbation (increase in dyspnoea, sputum purulence and sputum volume)

Excluded if
  • bronchiectasis
  • severe concomitant disorders likely to interfere with clinical course (cystic fibrosis, uncontrolled cardiovascular disorders, cancer or AIDs)
  • hepatic disease (AST or ALT >twice or bilirubin >1.5 times the upper limit of normal)
  • renal failure (serum creatinine >170 µ mol/L)
  • anaemia (haemoglobin <10 g/dL)
  • history of photosensitivity or allergy to quinolones or ß -lactams
  • serious psychiatric disease
  • concomitant administration of iron salts, allopurinol or administration of any investigational drug within 1 month of study entry
  • <18 years old
  • FEV1/FVC ratio of >70%
  • pneumonia


    • Control Group: (n = 363, 286 analysed): co-amoxiclav 500 mg/125 mg three times daily for 7 to 14 days, plus a matching placebo
    Experimental Group: (n = 370, 302 analysed): sparfloxacin 200 mg loading dose on first day, followed by 100 mg once daily for 7 to 14 days, plus a matching placebo

    100% followed for 10 days
    Outcome notes:
    • clinical success : Cure (return to baseline stable state in all three clinical symptoms) or improvement (decrease in all three symptoms or return of both sputum volume and purulence to baseline stable state with dyspnoea unchanged)

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    clinical success 10 days 272
    (95.1%)    		 280
    (92.7%)    		 -49%
    (-185% to 22%)    		 -2.39%
    (-6.24% to 1.46%)    		 -42
    (NNT = 68 to infinity;
    NNH = 16 to infinity)
    adverse effects 10 days 93
    (32.52%)    		 81
    (26.82%)    		 18.0%
    (-6% to 36%)    		 5.70%
    (-1.68% to 13.07%)    		 18
    (NNT = 8 to infinity;
    NNH = 59 to infinity)

  • Follow-up was 10 days after treatment ended.

    • Comments

    1. The study is too small to show any clear difference in clinical success or adverse effects between the two groups.

    Citation

    1. Allegra L, Konietzko N, Leophonte P, et al: Comparative safety and efficacy of sparfloxacin in the treatment of acute exacerbations of chronic obstructive pulmonary disease: a double-blind, randomised, parallel, multicentre study. Journal of Antimicrobial Chemotherapy 1996; 37 (Suppl.A): 93-104
    Search Terms: COPD and therapy in Medline
    Contributor: Clare Wotton and Musab Hayatli, November 1999
    Reviewer: Mitsuhiro Kamei

    Clinical Question.
    Patient acute exacerbation of COPD
    Intervention or Exposure sparfloxacin
    Comparison amoxicillin/clavulanic acid
    Outcome clinical success