Clinical phase III study of oral garenoxacin in patients with community-acquired acute respiratory infection

The clinical efficacy and safety of garenoxacin(GRNX), a novel des-fluoroquinolone, were observed in patients with respiratory tract infection including community-acquired pnuemonia and acute bronchitis caused by Mycoplasma pneumoniae, Chlamydia pneumoniae or Streptococcus pneumoniae, community organisms. All patients were treated with 400 mg once daily dose of GRNX for 7-10 days. 1. Clinical efficacy: The efficacy rate at the end day of treatment was 98.9% (88/89) in all cases of community-acquired pnuemonia, including pneumonia with M. pneumoniae 100% (20/20), with C. pneumoniae 923% (12/13) and with common bacterial organisms 100% (56/56). The efficacy rate for acute bronchitis was observed in 100% (13/13), including 12 cases with bacteria and 1 case with C. pneumoniae. 2. Bacteriological efficacy: The eradication rate at the end day of treatment was 81.8% (27/33) in all cases of community-acquired pnuemonia, including pneumonia with M. pneumoniae 6/6 and with common bacterial organisms 95.5% (21/22). The eradication rate for acute bronchitis was observed in 5/5. Bacteriological response with 5 cases of mixed infection caused by bacteria, M. pneumoniae and C. pneumoniae was judged as partial eradication. 3. Safety: Adverse reactions involving 233 were observed in 93 cases of 144 cases (64.6%). Some 103 events of the side effects and drug induced laboratory abnormalities were observed in 55 out of 144 cases (38.2%). Abnormalities seen most frequently were increases in ALT and AST, but the incidence was 10.5% (15/143) in the former and 5.6% (8/143) in the latter. From above findings of GRNX, a 400 mg oral dose once daily treatment may be useful for patients with respiratory tract infections including mycoplasma pneumonia, chlamydia pneumonia and acute bronchitis.