To compare the safety and efficacy of gemifloxacin to high dose amoxicillin/clavulanate (amox/clav) for the treatment of CAP of suspected pneumococcal origin (based on clinical characteristics including gram stain findings of sputum).
Randomized, multicenter, double-blind, double-dummy study. 324 patients with CAP received oral gemifloxacin 320mg once daily for 7 days or oral amox/clav 1g/125mg 3 times daily for 10 days. Outcome measures were clinical, bacteriological, and radiological responses at the end of therapy (EOT; Day 12–14) and follow-up (FU; Day 24–30).
In 228 Per Protocol (PP) patients, clinical resolution at FU was 88.7% for gemifloxacin and 87.6% for amox/clav [95% CI -7.3,9.5]. Clinical resolution at EOT was 95.3% for gemifloxacin vs. 90.1% for amox/clav.[ 95%CI, -1.2, 11.7] Bacteriologic responses for PP patients at EOT were 96.3% for 7-day gemifloxacin and 91.8% for the amox/clav group [95%CI, -4.7, 13.6], and at FU were 87.2% for gemifloxacin and 89.1% for the amox/clav group [95%CI -15.0, 11.2]. Gemifloxacin eradicated 95.7% (22/23) and amox/clav eradicated 100% (21/21) of Streptococcus pneumoniae including penicillin- and macrolide-resistant strains. Radiological responses at EOT were 89.1% for gemifloxacin and 87.6% for amox/clav. The most frequently reported drug-related events were in the gemifloxacin group, diarrhea (6.0%) and rash (3.0%) and in the amox/clav group, diarrhea (11.1%) and fungal infection, vaginitis and vomiting (each 2.0%). There were statistically fewer withdrawals due to lack of therapeutic effect in the gemifloxacin group (2/33; 6%) vs the amox/clav cohort (9/33; 27%), (95% CI -8.8;0.6; p=0.03).
Gemifloxacin 320 mg once daily for 7 days was clinically, bacteriologically, and radiologically as effective as 10 days of amox/clav 1g/125mg 3 times daily for the treatment of suspected pneumococcal CAP.
Gemifloxacin represents a valuable addition to the therapeutic options to treat CAP.
T. File, None.