Early phase II clinical study of gatifloxacin, an oral new quinolone, for infections in the field of internal medicine

A. Saito, I. Nakayama, M. Ohmichi, M. Tomizawa, Y. Nakai, Y. Honda, A. Watanabe, M. Arakawa, K. Wada, N. Aoki, O. Sekine, Y. Suzuki, O. Sakai, K. Shiba, H. Tanimoto, T. Nakatani, K. Nakata, I. Hayashi, M. Sakurai, H. ShishidoH. Watanabe, S. Irimajiri, M. Obana, J. Shimada, S. Hori, F. Matsumoto, T. Imai, I. Sakurai, K. Yoshikawa, S. Odagiri, K. Suzuki, H. Takahashi, Y. Yoshiike, T. Ogura, A. Sato, K. Chida, H. Okano, M. Iwata, M. Ida, A. Okano, Y. Nakano, I. Shichi, J. Morita, K. Shimokata, S. Ichiyama, M. Yamamoto, A. Kawabata, T. Yagi, T. Murate, K. Imaizumi, J. Ohno, S. Sakai, K. Senda, Y. Totani, F. Kuze, T. Murayama, N. Fujimori, N. Ikeda, H. Yamadori, K. Bando, H. Nishimura, Y. Mochizuki, Y. Nakahara, T. Kawamura, R. Kawanami, T. Kato, K. Tsuyuguchi, F. Miki, N. Narita, K. Mikasa, R. Soejima, N. Okimoto, Y. Niki, T. Matsushima, Y. Tano, T. Sasaki, Y. Matsumoto, Y. Sugimoto, K. Oizumi, N. Tokunaga, Y. Sawae, K. Matsumoto, K. Oishi, K. Hara, M. Kaku, H. Sugiyama, T. Oe, R. Fukuda, M. Nasu, T. Yamasaki, J. Inadome, H. Fukuhara

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2 Citations (Scopus)

Abstract

We investigated the clinical and bacteriological efficacy, safety, usefulness and fluid concentrations of gatifloxacin (GFLX) for the treatment of infections in the field of internal medicine. The subjects were 170 patients with respiratory tract infection and 2 with urinary tract infection. GFLX was administered in once-daily or twice-daily doses of 100, 150 or 200 mg for 3 to 14 days. The results were as follows: 1. Clinical efficacy was evaluated in 172 cases, and the majority had received twice-daily doses. The overall clinical efficacy rate (excellent or good) was 94.2% (162/172). 2. Bacteriological efficacy was evaluated in 72 cases of identified bacteria. The eradication rate was 90.3% (65/72). 3. Side effects were evaluated in 192 cases, and their incidence was 4.2% (8/192). Laboratory test findings were evaluated in 156 cases, and the incidence of abnormal findings was 10.3% (16/156). 4. Clinical usefulness was evaluated in 175 cases. The usefulness rate (very useful or useful) was 90.9% (159/175). 5. Serum and sputum concentrations of GFLX were measured after the first dose of 200 mg twice daily, and the maximum sputum concentration was 2.13 μg/mL. The sputum to serum concentration ratio was 1.09 μg/mL. These results suggest the favorable penetration of GFLX. The results indicate good clinical and bacteriological efficacy of GFLX, as well as, its satisfactory penetration into sputum. Therefore, it was concluded that GFLX would be a useful antimicrobial drug and that the dosage of 100 to 200 mg twice daily is well tolerated and satisfactory for the treatment of infections in the field of internal medicine.

Original languageEnglish
Pages (from-to)260-276
Number of pages17
JournalJapanese Journal of Chemotherapy
Volume47
Issue numberSUPPL. 2
Publication statusPublished - 1999

Keywords

  • GFLX

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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