Clinical phase III open-labeled study of oral garenoxacin in patients with respiratory tract infection by penicillin-resistant Streptococcus pneumoniae

The efficacy and safety of garenoxacin mesilate hydrate (GRNX), a novel oral des-fluoroquinolone, were evaluated in patients with respiratory tract infection caused by penicillin-intermediate resistant S.pneumo-niae(FlSP) and penicillin-resistant S. pneumoniae(PRSP). 1. Clinical efficacy: The efficacy rates at the end of treatment in patients caused by PISP, PRSP, and penicillin-susceptible S. pneumoniae(PSSP) pathogens were 8/9,93.8% (15/16) and 100% (22/22). The efficacy rate in patients with resistance-unknown S. pneumoniae was 4/4, and the total efficacy rate was 96.1% (49/ 51). The efficacy rates at 3 days after treatment in total, PRSP, PISP, PSSP and resistance-unknown strains were 84.3% (43/51), 8/9,75.0% (12/16) and 4/4. 2. Bacteriological efficacy: The eradication rates at 3 days after treatment or at the end of treatment in total, PRSP, PISP, PSSP and resistance-unknown strains were 100% (50/50), 9/9, 100% (16/16), 100% (21/21) and 4/4. 3. Safety: Incidence of adverse events and laboratory abnormalities were 8.1% (8/99) and 30.3% (30/99). No strange event was observed. No clinically relevant electrocardiogram abnormalities mere noted. Results suggest that 400 mg daily treatment of GRNX administered is useful for patients with respiratory tract infection including patients caused by penicillin-resistant S. pneumoniae.