Phase III double-blind comparative study of BAY 12-8039 (moxifloxacin) versus levofloxacin in patients with community-acquired pneumonia

Accession number;06A0013877
Title;Phase III double-blind comparative study of BAY 12-8039 (moxifloxacin) versus levofloxacin in patients with community-acquired pneumonia
Author; KOBAYASHI HIROYUKI (Kyorin Univ., School of Medicine, JPN) AOKI NOBUKI (Niigata-shi Shakai Jigyo Kyokai Shinrakuen Byoin, JPN) NIKI YOSHIHITO (Kawasaki Medical School, JPN) WATANABE AKIRA (Res. Inst. Tuberculosis and Cancer, Tohoku Univ.) KAWAI SHIN (Kyorin Univ., School of Medicine, JPN) ODAGIRI SHIGEKI (Kanagawa Prefectural Cardiovascular and Respiratory Diseases Center, JPN) KONO SHIGERU (Nagasaki Univ., Grad. Sch.) YAMAGUCHI KEIZO (Toho Univ., School of Med.) SAITO ATSUSHI (Univ. of Ryukyus, Grad. Sch.)
Journal Title;Japanese Journal of Chemotherapy
Journal Code:F0608A
ISSN:1340-7007
VOL.53;NO.Supplement 3;PAGE.27-46(2005)
Figure&Table&Reference;FIG.2, TBL.15, REF.24
Pub. Country;Japan
Language;Japanese
Abstract;The clinical efficacy and safety of moxifloxacin (MFLX), a novel new quinolone compound, and levofloxacin (LVFX) were compared in the treatment patients with community-acquired pneumonia in a double-blind, randomized, group comparative study. Patients were treated for 10 days with either MFLX 400 mg orally once daily (MFLX group) or LVFX 100 mg three times daily (LVFX group). Overall clinical reponse in 246 patients evaluable for efficacy were 94.0% (110/117 patients) in the MFLX group and 94.6% (122/129) in the LVFX group. It was demonstrated that MFLX is not inferior to LVFX. Overall bacteriological response in 86 patients evaluable for bacteriological efficacy was 92.3% (36/39 patients) in the MFLX group and 82.6% (38/46) in the LVFX group. Eradication rate by causative organisms in overall bacteriological response was 92.7% (38/41) in the MFLX group and 84.3% (43/51) in the LVFX group. The incidence rate of adverse drug reaction was 16.8% (25/149 patients) in the MFLX group and 11.1% (17/153) in the LVFX group. The above results suggested that a 400 mg oral dose of MFLX once daily for 10 days should be very useful clinically in the treatment of community-acquired pneumonia. (author abst.)