To assess the efficacy of once daily gemifloxacin in the treatment of CAP.
Six clinical studies were conducted with adult patients suffering from CAP. Gemifloxacin (320mg qd 7 or14 days) was compared to amoxicillin/clavulanate (1g/125mg tid 10 days), cefuroxime/clarithromycin (500mg/500mg bid 7 or14 days), trovafloxacin (200mg qd 7 or14 days) and IV ceftriaxone/oral cefuroxime (2g qd/500mg bid 1–7 days + 1–13 days). Outcome measures were clinical, bacteriological, and radiological responses at follow-up.
Clinical resolution was 90.5% for the combined gemifloxacin group compared with 91.1% for the combined comparators. Bacteriological response rates were 88.9% for gemifloxacin and 88.7% for the combined comparator group. Radiological response rates were between 87.9% and 94.0% for gemifloxacin and between 87.6% and 94.2% for the comparators. Gemifloxacin achieved 100% (12/12) eradication of penicillin-resistant S. pneumoniae (MIC ≥2ug/mL ) and was similarly effective in patients with macrolide-resistant S. pneumoniae. 14/16 (87.5%) patients with erythromycin-resistant S. pneumoniae and 19/22 (86.4%) patients with clarithromycin-resistant S. pneumoniae achieved clinical and bacteriological success at follow-up. Gemifloxacin was effective against CAP due to multi-drug resistant S. pneumoniae (MDRSP), i.e., S. pneumoniae resistant to 2 or more of the following: penicillin, second generation cephalosporins, macrolides, tetracyclines and TMP/SMX. Of 22 patients with MDRSP treated for 7 days, 19 (86.5%) achieved clinical and bacteriological success at follow-up. Of the pathogens isolated from these patients, 11 were penicillin-resistant, 19 macrolide-resistant, 16 TMP-SMX-resistant, 16 tetracycline-resistant and 14 resistant to a second generation cephalosporin.
Gemifloxacin 320 mg once daily for 7 days was found to be at least as effective clinically, bacteriologically and radiologically as the comparator regimens for the treatment of CAP.
Gemifloxacin offers an effective new option in the treatment of CAP.
B. Carlin, None.