Adult inpatients and outpatients with a diagnosis of community-acquired bacterial pneumonia were evaluated in two pivotal clinical studies. In the first study, 590 patients were enrolled in a prospective, multicenter, unblinded randomized trial comparing levofloxacin 500 mg once daily orally or intravenously for 7 to 14 days to ceftriaxone 1 to 2 grams intravenously once or in equally divided doses twice daily followed by cefuroxime axetil 500 mg orally twice daily for a total of 7 to 14 days. Patients assigned to treatment with the control regimen were allowed to receive erythromycin (or doxycycline if intolerant of erythromycin) if an infection due to atypical pathogens was suspected or proven. Clinical and microbiologic evaluations were performed during treatment, 5 to 7 days post-therapy, and 3 to 4 weeks post-therapy. Clinical success (cure plus improvement) with levofloxacin at 5 to 7 days post-therapy, the primary efficacy variable in this study, was superior (95%) to the control group (83%). The 95% CI for the difference of response rates (levofloxacin minus comparator) was [-6, 19]. In the second study, 264 patients were enrolled in a prospective, multicenter, non-comparative trial of 500 mg levofloxacin administered orally or intravenously once daily for 7 to 14 days. Clinical success for clinically evaluable patients was 93%. For both studies, the clinical success rate in patients with atypical pneumonia due to Chlamydophila pneumoniae, Mycoplasma pneumoniae and Legionella pneumophila were 96%, 96% and 70%, respectively. Microbiologic eradication rates across both studies are presented in Table 12.
|Pathogen||No. Pathogens||Microbiologic Eradication Rate (%)|
Levofloxacin was effective for the treatment of community-acquired pneumonia caused by multi-drug resistant Streptococcus pneumoniae (MDRSP). MDRSP isolates are strains resistant to two or more of the following antibacterials: penicillin (MIC ≥ 2 mcg/mL), 2nd generation cephalosporins (e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole). Of 40 microbiologically evaluable patients with MDRSP isolates, 38 patients (95%) achieved clinical and bacteriologic success at post-therapy. The clinical and bacterial success rates are shown in Table 13.
|Screening Susceptibility||Clinical Success||Bacteriological Success *|
|n/N †||%||n/N ‡||%|
|2nd generation Cephalosporin resistant||31/32||96.9||31/32||96.9|
|Trimethoprim/ Sulfamethoxazole resistant||17/19||89.5||17/19||89.5|
Not all isolates were resistant to all antimicrobial classes tested. Success and eradication rates are summarized in Table 14.
|Type of Resistance||Clinical Success||Bacteriologic Eradication|
|Resistant to 2 antibacterials||17/18 (94.4%)||17/18 (94.4%)|
|Resistant to 3 antibacterials||14/15 (93.3%)||14/15 (93.3%)|
|Resistant to 4 antibacterials||7/7 (100%)||7/7 (100%)|
|Resistant to 5 antibacterials||0||0|
|Bacteremia with MDRSP||8/9 (89%)||8/9 (89%)|
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