Phase II study of intravenously infused pazufloxacin mesilate

K. Shimada, S. Oka, Y. Sano, Y. Arai, T. Inamatsu, S. Abe, T. Igarashi, Y. Kawakami, E. Yamaguchi, Y. Nishiura, Y. Hiraga, M. Ohmichi, T. Nukiwa, A. Watanabe, K. I. Takeuchi, H. Hirano, K. Sato, T. Nakamura, H. Inoue, K. KonishiK. Shiba, K. Okada, H. Kobayashi, S. Kawai, H. Oshitani, O. Kunii, H. Nishiya, J. Shimada, S. Hori, H. Shishido, A. Kurashima, M. Baba, M. Koyama, I. Hayashi, K. Kudo, N. Kobayashi, S. Odagiri, K. Suzuki, Y. Hirai, F. Matsumoto, I. Sakurai, T. Imai, S. Irimajiri, Y. Matsuoka, N. Koido, S. Kitamura, Y. Sugama, O. Sekine, Y. Suzuki, M. Matuda, N. Aoki, M. Arakawa, K. Wada, H. Tsukada, F. Iwata, S. Hoshino, A. Iwashima, A. Sato, K. Chida, K. Takagi, T. Takeuchi, H. Hanaki, T. Yamamoto, S. Fukuhara, S. Yonezu, N. Narita, K. Mikasa, F. Miki, T. Sasaki, Y. Matsumoto, Y. Sugimoto, R. Soejima, Y. Niki, N. Okimoto, O. Moriya, K. Yoshida, T. Matsushima, M. Kimura, M. Yamakido, N. Yamaoka, Y. Sawae, K. Takaki, K. Oizumi, M. Kinoshita, T. Ishibashi, M. Takamoto, Y. Harada, S. Harada, A. Kajiki, Y. Kitahara, H. Yamada, M. Kawashima, K. Hara, S. Kohno, K. Tomono, S. Maesaki, Y. Hirakata, Y. Miyazaki, Y. Inoue

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1 Citation (Scopus)

Abstract

The clinical efficacy, safety, and usefulness of intravenously infused pazufloxacin (PZFX), a pyridonecarboxylic acid derivative, were evaluated for treatment of moderate to severe respiratory tract infections. In this study, patients were treated with PZFX by intravenous drip infusion at a dose of 300 or 500 mg, twice or three times a day for 3 to 14 days. The results obtained are as follows: 1. Among the 278 patients enrolled, 241 cases, 253 cases, and 236 cases were adopted to analyze efficacy, safety, and usefulness, respectively. 2. The clinical efficacy rate in respiratory tract infections was 75.1% (181/241) overall, 76.1% (67/88) for chronic respiratory tract infections, and 75.7% (109/144) for pneumonia/lung suppuration. The clinical efficacy rate in poor responders to other antimicrobial agents, was 63.3% (38/60). The clinical efficacy rate classified by daily dose was 74.2% (49/66) in the 600 mg dosing group and 74.7% (124/166) in the 1000 mg dosing group. The causative-organism elimination rate was 69.2% (72/104) overall. 3. Side effects were noted in 11 cases (4.0%) and consisted of central nervous system disorders in 3 cases, allergy symptoms in 2 cases, gastrointestinal symptoms in 5 cases, and dry mouth in 1 case. Abnormal laboratory findings were noted in 36 cases (14.3%) mainly consisting of serum transaminase elevation in 16 cases and eosinophilia in 12 cases. 4. The usefulness rate for respiratory tract infections was 72.9% (172/236) overall. The usefulness rate according to daily dose was 71.4% (45/63) in the 600 mg dosing group and 72.6% (119/164) in the 1000 mg dosing group. Based on the above findings, intravenously infused PZFX seems to be effective, safe, and useful for the treatment of patients with moderate to severe respiratory tract infections.

Original languageEnglish
Pages (from-to)176-195
Number of pages20
JournalJapanese Journal of Chemotherapy
Volume47
Issue numberSUPPL. 1
Publication statusPublished - 1999
Externally publishedYes

Keywords

  • Pazufloxacin (PZFX)

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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