Community-acquired pneumonia: sparfloxacin decreased early relapse.

Clinical bottom line (level 1b)

  1. Patients with community-acquired pneumonia who are given sparfloxacin had no clear difference in clinical success, than those given high-dose amoxicillin.
  2. Patients given sparfloxacin were less likely to have early relapse than those given amoxicillin (NNT = 22 at 41 days) .
  3. There was no clear difference in gastrointestinal disturbances.
Aubier et al: Clinical Infectious Disease 1998; 26: 1312-1320
Expires March 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 46 centres, France, South Africa and Switzerland

329 patients (aged mean 42 years, 87% male) Hospitalised for a presumed diagnosis of pneumococcal community-acquired pneumonia (fever, temperature >38 ° C; a new alveolar infiltrate evident on chest radiograph; at least one sign or symptom, cough, dyspnea, chills or purulent sputum production). Presumptive diagnosis was made if at least two of the following were present: sudden onset, fever (>39 ° C) with chills, chest pain, localised alveolar consolidation evident on chest radiograph and exclusive or predominant presence of gram-positive cocci with the appearance of S. pneumoniae in a smear of a respiratory sample.

Excluded if
  • <18 years old
  • allergic to quinolones or penicillins
  • severe infection requiring parenteral antibiotic therapy
  • severe concomitant disorder likely to interfere with the clinical course of pneumonia
  • AIDS (but HIV were included)
  • drug abuse habit
  • severe neuropsychiatric disease
  • hepatic disease (aspartate aminotransferase or alanine aminotransferase level >3 times the upper limit of normal or bilirubin level >1.5 times upper limit of normal)
  • cirrhosis
  • chronic renal failure (creatinine level >200 mmol/L)
  • white blood cell count of <4000/ µ L or >20000/ µ L
  • pregnancy or lactating
  • concomitant use of antacids, systemic corticosteroids, allopurinol and iron salts
  • prior antibiotic therapy for this pneumonia that lasted >24 hours


    • Control Group: (n = 170, 170 analysed): amoxicillin , two 500 mg capsules three times daily for 10 days
    Experimental Group: (n = 159, 159 analysed): sparfloxacin , 400 mg on day 1 and 200 mg daily for 10 days(placebo was given three times daily as well)

    100% followed for 41 days
    Outcome notes:
    • overall success : Cure (absence of fever, chills, chest pains, cough or dyspnoea and the absence of sputum production) or improvement (absence of chills and fever, but other symptoms such as chest pain, cough or sputum production could still be present).
    • early failure : relapse at follow-up visit

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    overall success 14 days 144
    (84.7%)    		 133
    (83.7%)    		 1.00%
    (-8.00% to 10.0%)    		 1.06%
    (-6.84% to 8.95%)    		 95
    (NNT = 11 to infinity;
    NNH = 15 to infinity)
    early failure 41 days 11
    (6.47%)    		 3
    (1.89%)    		 71.0%
    (-3.00% to 92.0%)    		 4.58%
    (0.32% to 8.84%)    		 22
    (11 to 309)
    gastrointestinal disturbances 41 days 19
    (11.18%)    		 10
    (6.29%)    		 44.0%
    (-17.0% to 73.0%)    		 4.89%
    (-1.17% to 10.94%)    		 20
    (NNT = 9 to infinity;
    NNH = 86 to infinity)

    Comments

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

    Citation

    1. Aubier M, Verster R, Regamey C, et al: Once-daily sparfloxacin versus high-dosage amoxicillin in the treatment of community-acquired, suspected pneumococcal pneumonia in adults. Clinical Infectious Disease 1998; 26: 1312-1320
    Search Terms: pneumonia and therapy in Medline
    Contributor: Clare Wotton and Musab Hayatli, November 1999
    Reviewer: Bruce Arroll

    Clinical Question.
    Patient community-acquired pneumonia
    Intervention or Exposure sparfloxacin
    Comparison amoxicillin
    Outcome clinical success