A dose-finding comparative study on tazobactam/piperacillin in chronic respiratory tract infection

Kotarou Oizumi, Akira Watanabe, Keizo Matsumoto, Kotarou Oizumi, Yoichirou Ichikawa, Naoto Tokunaga, Masako Tanaka, Masakichi Motomiya, Akira Watanabe, Kiyoshi Konno, Satoru Shoji, Kuniharu Shida, Kazuo Satoh, Kazunao Niizuma, Shigeo Takizawa, Mikae Nakamura, Kenji Yanase, Yoshiyuki Mitsutake, Utako Aoyagi, Masashi KawaharaMasazumi Saisho, Hironari Sigematsu, Toshihiko Harada, Akira Nagata, Masaki Tsuru, Yumi Fukuda, Kohzabu Ishii, Shouko Tanoue, Kazuma Fujino, Fumio Tanaka, Hiroaki Furuno, Takaoki Ohtsuka, Keizo Matsumoto, Tsuyoshi Nagatake, Kazunori Ohishi, Teruyuki Miyazaki, Mikio Taguchi, Hirofumi Tanaka, Hidehiko Hirose, Masakazu Takasugi, Hidefumi Ishikawa, Toshihiro Morito, Hiroyuki Yoshimine, Harumi Shishido, Hideaki Nagai, Hisashi Watanabe, Shinobu Akagawa, Naoto Rikitomi, Tasuku Sakamoto, Nobuya Ogawa

Research output: Contribution to journalArticle

Abstract

A dose-finding study on tazobactam/piperacillin (TAZ/PIPC), a combination of a new β-lactamase inhibitor, tazobactam (TAZ), and piperacillin (PIPC) at a ratio of 1: 4, was conducted by comparative design in patients with chronic respiratory tract infections. The low dose group of TAZ/PIPC (group L) received TAZ/PIPC at a daily dose of 2.5 g (b. i. d.). The high dose group of TAZ/PIPC (group H) received TAZ/PIPC at a daily dose of 5.0 g (b. i. d.). The PIPC group as a control (group C) received a daily dose of 4.0 g of PIPC (b. i. d). Drugs were administered by intravenous drip infusion for 14 days. The total number of patients entered in the trial was 78, of which 75 patients (25, 27 and 23 in groups L, H, and C, respectively) were evaluable for clinical efficacy and 76 (25, 27 and 24 as grouped and ordered above) for side effects. 1) The patient characteristics were well balanced among the three groups. 2) The overall clinical efficacy rates were 92.0% for L, 92.6% for H and 91.3% for C. The clinical efficacy rates in patients infected with β-lactamase producers were 71.4% for L, 100.0% for H and 100.0% for C. There was no significant difference among the three groups. 3) The bacterial eradication rates were 68.8% for L, 100.0% for H and 87.5% for C. All causative organisms in group H were eradicated, but there was no significant difference among the three groups. The eradication rates of β-lactamase producers were 57.1% for L, 100.0% for H and 75.0% for C. 4) Side effects were observed in only 2 patients of group C. Abnormal laboratory findings were observed at rates of 4.0%, 3.7% and 8.7% in groups L, H, and C, respectively. There was no significant difference in the two categories of safety evaluations (symptoms and signs, abnormalitiesof laboratory findings). The overall safety ratings (safe and almost safe) were 100.0%, 100.0%, and 87.5%. 5) The usefulness rates were 92.0% for L, 92.6% for H, and 79.2% for C, with no significant difference among the three groups. As mentioned above, the eradication rate was highest in group H, and there was no significant difference in safety among the three groups. Therefore, a daily dose of 5.0 g (b. i. d.) of TAZ/PIPC was considered to be appropriate for chronic respiratory tract infections.

Original languageEnglish
Pages (from-to)482-500
Number of pages19
JournalChemotherapy
Volume42
DOIs
Publication statusPublished - 1994 Jan 1
Externally publishedYes

Keywords

  • tazobactam/piperacillin
  • β-lactamase inhibitor

ASJC Scopus subject areas

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

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  • Cite this

    Oizumi, K., Watanabe, A., Matsumoto, K., Oizumi, K., Ichikawa, Y., Tokunaga, N., Tanaka, M., Motomiya, M., Watanabe, A., Konno, K., Shoji, S., Shida, K., Satoh, K., Niizuma, K., Takizawa, S., Nakamura, M., Yanase, K., Mitsutake, Y., Aoyagi, U., ... Ogawa, N. (1994). A dose-finding comparative study on tazobactam/piperacillin in chronic respiratory tract infection. Chemotherapy, 42, 482-500. https://doi.org/10.11250/chemotherapy1953.42.Supplement2_482