A MULTICENTER, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF INTRAVENOUS AND OR ORAL LEVOFLOXACIN VERSUS CEFTRIAXONE AND/OR CEFUROXIME AXETIL IN TREATMENT OF ADULTS WITH COMMUNITY-ACQUIRED PNEUMONIA/

Five hundred ninety patients were enrolled in a prospective, multicent er, randomized trial comparing the efficacy and safety of 7 to 14 days of levofloxacin treatment with that of ceftriaxone and/or cefuroxime axetil in the management of community-acquired pneumonia in adults. Pa tients received either intravenous and/or oral levofloxacin (500 mg on ce daily) or the comparative agents, parenteral ceftriaxone (1 to 2 g once to twice daily) and/or oral cefuroxime axetil (500 mg twice daily ). Erythromycin or doxycycline could be added to the comparator arm at the investigator's discretion. The decision to use an intravenous or oral antimicrobial agent for initial therapy was made by the investiga tor. Clinical and microbiological evaluations were completed at the ba seline, during treatment, 5 to 7 days posttherapy, and 3 to 4 weeks po sttherapy. Four hundred fifty-six patients (226 given levofloxacin and 230 administered ceftriaxone and/or cefuroxime axetil) were evaluable for clinical efficacy. Streptococcus pneumoniae and Haemophilus influ enzae were isolated in 15 and 12%, respectively, of clinically evaluab le patients. One hundred fifty atypical pathogens were identified: 101 were Chlamydia pneumoniae, 41 were Mycoplasma pneumoniae, and 8 were Legionella pneumophila. Clinical success at 5 to 7 days posttherapy wa s superior for the levofloxacin group (96%) compared with the ceftriax one and/or cefuroxime axetil group (90%) (95% confidence interval [CI] of -10.7 to -1.3). Among patients with typical respiratory pathogens who were evaluable for microbiological efficacy, the overall bacteriol ogic eradication rates were superior for levofloxacin (98%) compared w ith the ceftriaxone and/or cefuroxime axetil group (85%) (95% CI of -2 1.6 to -4.8). Levofloxacin eradicated 100% of the most frequently repo rted respiratory pathogens (i.e., H. influenzae and S. pneumoniae) and provided a >98% clinical success rate in patients with atypical patho gens. Both levofloxacin and ceftriaxone-cefuroxime axetil eradicated 1 00% of the S. pneumoniae cells detected in blood culture. Drug-related adverse events were reported in 5.8% of patients receiving levofloxac in and in 8.5% of patients administered ceftriaxone and/or cefuroxime axetil. Gastrointestinal and central and peripheral nervous system adv erse events were the most common events reported in each treatment gro up. In conclusion, these results demonstrate that treatment with levof loxacin is superior to ceftriaxone and/or cefuroxime axetil therapy in the management of community-acquired pneumonia in adults.