Postmarketing clinical study on cefozopran in comparison with ceftazidime for lower respiratory tract infection

Fumio Miki, Hiroyuki Kobayashi, Naruhiko Sugihara, Hiroaki Takeda, Yoshinori Nakazato, Hiroshi Sugiura, Susumu Sakayori, Eiichiro Sakagawa, Yoshinobu Ohsaki, Shinobu Osanai, Hiroshe Ide, Yutaka Nishigaki, Tadakatsu Tsuji, Hiroyuki Matsumoto, Yasuhiro Yamazaki, Yuka Fujita, Shoko Nakao, Masaaki Takahashi, Eri Toyoshima, Shuji YamaguchiAkira Shida, Nao Odajima, Takashi Yoshikawa, Kenshi Aoki, Mariko Ozasa, Ken Osonoi, Meishun Boku, Hiroshi Inoue, Shigeru Sakurai, Harukata Ito, Takashi Mohri, Susumu Takahashi, Chieko Inoue, Kiyokazu Higuchi, Akira Watanabe, Tohru Kikuchi, Hideki Ikeda, Hiroyuki Nakai, Yoshihiro Honda, Satoshi Shoji, Katsunao Niitsuma, Yasutoshi Suzuki, Nobuki Aoki, Kohichi Wada, Katsuhiro Kuwahara, Tetsuji Karino, Kazuhiko Shibata, Kohichiro Nakata, Kohji Narui, Yasuyuki Sano, Mamoru Ohtomo, Naohito Suzuki, Masaru Koyama, Kohya Shiba, Kazuhisa Okada, Masakatsu Saji, Toshie Akutsu, Yoshitaka Nakamori, Naohiko Chohnabayashi, Rokuroh Matsuoka, Hideaki Nagai, Yukio Suzuki, Wataru Takeshita, Jingoroh Shimada, Kazuo Ishida, Takemasa Nakagawa, Masaaki Shibamoto, Toshio Nakamura, Yuhko Komase, Moto O. Arai, Toshiki Shimada, Yasushi Nakazawa, Shigeki Odagiri, Yuji Watanuki, Ryuichi Nishihira, Yoshihiro Hirai, Makoto Kudoh, Chikao Suzuki, Yasuhiro Yoshiike, Hirotada Ikeda, Motoyoshi Suzuki, Masanori Nishikawa, Kenichi Takahashi, Kunihiko Ikehara, Masao Nakamura, Toshiharu Fuyuki, Shigeto Takagi, Kenji Yanase, Kunio Dote, Kazuhide Yamamoto, Masahiro Yamakoshi, Masashi Yamamoto, Genshi Itoh, Kohichiro Shima, Atsushi Watanabe, Kohsuke Takahashi, Yoshiyuki Sawa, Tsutomu Yoshida, Hitoshi Asamoto

    Research output: Contribution to journalArticle

    Abstract

    To demonstrate the rapid therapeutic effect of cefozopran (CZOP), an injectable cephalosporin antibacterial agent, we conducted a postmarketing comparative study in patients with lower respiratory tract infections, using ceftazidime (CAZ) as a control. Patients were given CZOP and CAZ at a dose of 1g (potency) twice daily for 7 days by intravenous drip infusion. Results were as follows: 1. A total of 412 patients were enrolled in the study, and 376 were included in the full analysis set (FAS). Judgment of clinical efficacy was not possible in 3. Efficacy (proportion of patients showing good responses) was 92.0% (173/188) for the CZOP group and 91.4% (169/185) for the CAZ group, which supported the noninferiority of CZOP to CAZ both at the 90% and 95% confidence intervals (two-sided). Stratified by disease, efficacy was 90.9% (120/132) in patients with bacterial pneumonia for the CZOP group and 93.3% (126/135) for the CAZ group. In patients with chronic respiratory infection, it was 94.6% (53/56) for the CZOP group and 86.0% (43/50) for the CAZ group, verifying the noninferiority of CZOP to CAZ both at the 90% and 95% confidence intervals (two-sided). 2. Bacteriological effects were evaluated in 210 patients in whom causative organisms were identified and the presence or absence of bacteria followed up. Eradication (proportion of patients in whom the causative organism was eradicated or replaced with another organism) was 89.5% (94/105) for the CZOP group and 90.5% (95/105) for the CAZ group. No significant difference was seen between groups. Eradication for individual causative organisms was 91.1% (113/124) for the CZOP group and 90.8% (108/119) for the CAZ group, showing no significant difference between groups. Eradication for S. pneumoniae, the most frequently isolated organism, was 100% (42/42) for the CZOP group and 89.5% (34/38) for the CAZ group, indicating a statistically significant difference (p = 0.047). Eradication on day 5 of treatment also favored the CZOP group over the CAZ group statistically significantly (p = 0.049). 3. The aim of therapy was achieved in 52.4% (99/189) of the CZOP group and 50.3% (94/187) of the CAZ group at completion of the study, requiring no additional treatment with antibacterial agents. No statistically significant difference was seen between groups in achieving the aim of therapy. 4. The incidence of adverse symptoms and signs was 3.9% (8/206) in the CZOP group and 5.0% (10/202) in the CAZ group. The incidence of abnormal alterations of laboratory variables was 31.6% (65/206) in the CZOP group and 32.2% (65/202) in the CAZ group. No statistically significant differences were seen between groups. Results indicate that CZOP is not inferior to CAZ in clinical efficacy. They also verified that CZOP has a rapid therapeutic effect in patients with lower respiratory tract infections caused by S. pneumoniae.

    Original languageEnglish
    Pages (from-to)526-556
    Number of pages31
    JournalJapanese Journal of Chemotherapy
    Volume53
    Issue number9
    Publication statusPublished - 2005 Sep

    Keywords

    • Cefozopran
    • Ceftazidime
    • Lower respiratory tract infection
    • Post-marketing clinical study
    • Therapeutic effect

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)

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