Dose-finding study of cefozopran for chronic respiratory tract infection

Hiroyuki Kobayashi, Shin Kawai, Fumio Miki, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, Rinzo Soejima, Yoshihito Niki, Masaru Sumi, Toshiharu Matsushima, Masayasu Kawanishi, Makoto Kimura, Makoto Ishida, Yoshihisa Matsumura, Hirofumi Adachi, Kuninori Tsukiyama, Osamu Moriya, Kohei Hara, Shigeru Kohno, Hironobu KogaMitsuo Kaku, Kohichi Watanabe, Seishin Nakano, Naomi Ito, Kazuo Sasayama, Toshiaki Hayashi, Masato Yatsugi, Kiyoyasu Fukushima, Tohru Fujino, Kenichi Tanaka, Sadahiro Asai, Hisashi Suyama, Hideo Mashimoto, Jun Araki, Tohru Ishino, Yuhichi Inoue, Masanori Iwamoto, Akira Ishizaki, Kenji Kawano, Kohta Kohno, Yoshito Tanaka, Takakazu Kitani, Shiro Kusano, Keizo Matsumoto, Tsuyoshi Nagatake, Atsushi Takahashi, Hidehiko Hirose, Hiroshi Tanaka, Mikio Taguchi, Masashi Yamamoto, Toshihiro Morito, Nobuya Ogawa

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

A dose-finding study was conducted to determine the optimal effective dosage of a cephem antebiotic, cefozopran (CZOP), administered for chronic respiratory tract infections, using acutely progressing cases as the study subjects, The daily dosage was set at 1 g of the study drug given in 2 divided doses (Group L) and 2 g given in 2 divided doses (Group H). This was contrasted with a daily dosage of 2 g of ceftazidime (CAZ) given in 2 divided doses as a control drug (Group C). The results of the study are summarized below. 1) Clinical efficacy: One case was judged to be “poor” and another case was designated “fair” in Group L and Group H. Group C also showed these results in 2 cases. The efficacy rate was 91.7% (11 cases of 12) for both Groups L and H, and 83.3% (10/12) for Control Group C. 2) Bacteriological effect: All of the 8 causative organisms completely disappeared in Group H, while the eradication rate was 90.9% (10/11) for Group L and 90.0% (9/10) for Group C. 3) Safety: As for side effects, one case in Group L developed rash, and fever was noted in one case in Group H. The appearance rate of abnormal laboratory findings was 23.1% (3/13) for Group L, 21.4% (3/14) for Group H, and 23.1% (3/13) for Group C. However, none of the symptoms or diagnose was serious. 4) Utility: Utility was rated to be 91.7% (11/12) for Group L, 100% (12/12) for Group H, and 83.3% (10/12) for Group C. Based on the above findings, the authors judged that the optimal daily dose is 1-2 g of cefozopran (in 2 divided doses) and thought it appropriate to conduct the Phase III Comparative Study using a daily dose of 2 g (in 2 divided doses) of cefozopran to examine its effectiveness in respiratory tract infections.

Original languageEnglish
Pages (from-to)863-877
Number of pages15
JournalChemotherapy
Volume41
Issue number8
DOIs
Publication statusPublished - 1993
Externally publishedYes

Keywords

  • cefozopran (CZOP)
  • chronic bronchitis
  • dose finding study

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Infectious Diseases
  • Pharmacology
  • Drug Discovery
  • Oncology

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  • Cite this

    Kobayashi, H., Kawai, S., Miki, F., Narita, N., Sawaki, M., Mikasa, K., Soejima, R., Niki, Y., Sumi, M., Matsushima, T., Kawanishi, M., Kimura, M., Ishida, M., Matsumura, Y., Adachi, H., Tsukiyama, K., Moriya, O., Hara, K., Kohno, S., ... Ogawa, N. (1993). Dose-finding study of cefozopran for chronic respiratory tract infection. Chemotherapy, 41(8), 863-877. https://doi.org/10.11250/chemotherapy1953.41.863