Clinical evaluation of pazufloxacin mesilate for chronic respiratory tract infections: Phase III comparative study of pazufloxacin mesilate versus ceftazidime

K. Shimada, S. Abe, T. Fujishima, K. Shirato, I. Ohno, M. Sakamoto, K. Konishi, T. Nukiwa, A. Watanabe, K. Niizuma, H. Takeda, H. Kobayashi, S. Kawai, T. Hosoya, K. Shiba, K. Okada, K. Kudo, N. Kobayashi, Y. Sano, Y. NakamoriM. Koyama, T. Horiuchi, S. Irimajiri, Y. Matsuoka, N. Koido, T. Mitsui, S. Odagiri, K. Suzuki, Y. Watanuki, O. Sekine, N. Aoki, K. Wada, S. Izumi, A. Sato, K. Chida, K. Hayakawa, T. Yagi, M. Iwata, A. Yoshitomi, K. Tukamoto, Y. Noda, K. Takagi, H. Taniguchi, Y. Tohda, S. Fukuhara, N. Tsuda, B. I. Umeda, T. Nishimura, N. Narita, K. Mikasa, M. Konishi, T. Matsushima, Y. Niki, N. Okimoto, T. Karino, S. Kawahara, A. Tada, M. Yamakido, T. Miyazawa, M. Kuwabara, T. Sasaki, K. Oizumi, M. Kinoshita, M. Kawahara, M. Takamoto, T. Ishibashi, S. Kohno, R. Oka, H. Hori, Y. Inoue, S. Fujino, T. Ishino, Y. Higashiyama, K. Okuno, K. Fukushima, T. Nagatake, M. Tao, M. Ando, M. Suga, K. Sato, K. Ito, T. Doi, T. Sakata, K. Tokunaga, K. Fukushima, H. Iwagoe, M. Nasu, H. Kawano, A. Saito, M. Tateyama, A. Ohhama, T. Kubota, M. Nakashima

Research output: Contribution to journalArticlepeer-review

Abstract

The clinical efficacy, safety and usefulness of pazufloxacin mesilate, a new quinolone for injection, were evaluated in chronic respiratory tract infections in a comparative study versus ceftazidime (CAZ). As a rule, patients received either 500 mg (as pazufloxacin) of pazufloxacin mesilate b.i.d, or 1,000 mg (potency) of CAZ b.i.d., intravenously, for 14 days (28 vials). The following results were obtained in this trial. 1. A total of 203 patients were evaluated in this study, and 155 of them, were evaluated for clinical efficacy. Cases evaluated for adverse effects, abnormal laboratory findings, overall safety and usefulness numbered 185, 172, 177 and 153, respectively. 2. The clinical efficacy rate were 93.2% (68/73) in the pazufloxacin mesilate group and 91.5% (75/82) in the CAZ group. Both groups showed high efficacy. Since the 90% confidence interval of the efficacy rate difference between the two groups was -6.6~10.0%, clinical equivalency (non- inferiority) of the pazufloxacin mesilate group to the CAZ group was demonstrated at Δ=10%. 3. Among the cases evaluated for clinical efficacy, the 84 cases in which causative organisms were isolated, were evaluated for bacteriological effects. The bacteriological eradication rate was 65.0% (26/40) in the pazufloxacin mesilate group and 90.2% (37/41) in the CAZ group, and the difference between the groups was statistically significant (p=0.014, χ2 test). 4. The incidence of side effects was 6.8% (6/88) in the pazufloxacin mesilate and 11.3% (11/97) in the CAZ group, and the difference between the groups was not siginificant. The incidence of abnormal laboratory findings was 14.3% (12/84) in the pazufloxacin mesilate group and 27.3% (24/88) in the CAZ group, and the difference was statistical significant (p=0.041, Fisher's exact probability method). None of the adverse effects were serious. 5. The safety rate was 79.3% (69/87) in the pazufloxacin mesilate group and 64.4% (58/90) in the CAZ group, and the difference was statistically significant (p=0.042, χ2 test). 6. The usefulness rates were 86.7% (65/75) in the pazufloxacin mesilate group and 80.8% (63/78) in the CAZ group, and the difference between the groups was not significant. These results indicate that pazufloxacin mesilate is one of the most effective drugs for chronic respiratory tract infections.

Original languageEnglish
Pages (from-to)464-494
Number of pages31
JournalJapanese Journal of Chemotherapy
Volume48
Issue number6
Publication statusPublished - 2000
Externally publishedYes

Keywords

  • Ceftazidime
  • Pazufloxacin

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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