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

Hiroyuki Kobayashi; Nobuki Aoki; Yoshihito Niki; Akira Watanabe; Shin Kawai; Shigeki Odagiri; Shigeru Kohno; Keizo Yamaguchi; Atsushi Saito

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

Hiroyuki Kobayashi, Nobuki Aoki, Yoshihito Niki, Akira Watanabe, Shin Kawai, Shigeki Odagiri, Shigeru Kohno, Keizo Yamaguchi, Atsushi Saito

Research output: Contribution to journal › Article › peer-review

3 Citations (Scopus)

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 MFTX 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.

Original language	English
Pages (from-to)	27-46
Number of pages	20
Journal	Japanese Journal of Chemotherapy
Volume	53
Issue number	SUPPL. 3
Publication status	Published - 2005 Dec

Keywords

Community-acquired pneumonia
Double-blind trial
Levofloxacin
Moxifloxacin

ASJC Scopus subject areas

Pharmacology
Pharmacology (medical)

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Phase III double-blind comparative study of BAY 12-8039 (moxifloxacin) versus levofloxacin in patients with community-acquired pneumonia. / Kobayashi, Hiroyuki; Aoki, Nobuki; Niki, Yoshihito; Watanabe, Akira; Kawai, Shin; Odagiri, Shigeki; Kohno, Shigeru; Yamaguchi, Keizo; Saito, Atsushi.

In: Japanese Journal of Chemotherapy, Vol. 53, No. SUPPL. 3, 12.2005, p. 27-46.

Research output: Contribution to journal › Article › peer-review

Kobayashi, Hiroyuki ; Aoki, Nobuki ; Niki, Yoshihito ; Watanabe, Akira ; Kawai, Shin ; Odagiri, Shigeki ; Kohno, Shigeru ; Yamaguchi, Keizo ; Saito, Atsushi. / Phase III double-blind comparative study of BAY 12-8039 (moxifloxacin) versus levofloxacin in patients with community-acquired pneumonia. In: Japanese Journal of Chemotherapy. 2005 ; Vol. 53, No. SUPPL. 3. pp. 27-46.

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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 MFTX 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.",

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AU - Kawai, Shin

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AU - Kohno, Shigeru

AU - Yamaguchi, Keizo

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AB - 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 MFTX 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.

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