Clinical evaluation of pazufloxacin mesilate for bacterial pneumonia: Phase III comparative study of pazufloxacin mesilate versus ceftazidime

K. Shimada, S. Abe, T. Fujishima, A. Honma, K. Shirato, I. Ohno, M. Takahashi, M. Ishii, S. Maeda, M. Sakamoto, K. Konishi, T. Nukiwa, A. Watanabe, K. Nagai, H. Takeda, T. Osonoi, H. Kobayashi, S. Kawai, T. Hosoya, K. ShibaK. Okada, K. Kudo, N. Kobayashi, Y. Sano, Y. Nakamori, M. Koyama, T. Horiuchi, H. Shishido, S. Mitarai, S. Irimajiri, Y. Matsuoka, N. Koido, I. Sakurai, F. Matsumoto, S. Odagiri, K. Suzuki, Y. Watanuki, M. Arakawa, K. Igarashi, O. Sekine, Y. Suzuki, 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, T. Kurasawa, F. Miki, Y. Tohda, B. I. Umeda, T. Nishimura, N. Narita, K. Mikasa, M. Konishi, T. Matsushima, Y. Niki, N. Okimoto, T. Karino, R. Soejima, M. Muguruma, S. Kawahara, A. Tada, M. Yamakido, S. Hozawa, T. Sasaki, K. Kono, K. Oizumi, M. Kinoshita, M. Kawahara, S. Kohno, M. Watanabe, R. Oka, H. Hori, Y. Inoue, S. Fujino, Y. Yamamoto, T. Ishino, H. Ohno, K. Okuno, K. Fukushima, T. Nagatake, M. Tao, M. Ando, M. Suga, S. Keizo, K. Ito, T. Doi, T. Sakata, M. Tamanoi, K. Tokunaga, K. Shimazu

    Research output: Contribution to journalArticle

    Abstract

    The clinical efficacy, safety, and usefulness of pazufloxacin mesilate, a new quinolone for injection, were evaluated in bacterial pneumonia or lung abscess 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 232 patients were evaluated in this study, and 185 of them (bacterial pneumonia: 173 cases; lung abscess: 12 cases) were evaluated for clinical efficacy. The cases evaluated for adverse effects, abnormal laboratory findings, overall safety, and usefulness amounted to 225, 208, 210, and 182, respectively. 2. The clinical efficacy rate was 90.7% (78/86) in the pazufloxacin mesilate group and 89.9% (89/99) in the CAZ group. Both groups showed high efficacy. Since the 90% confidence interval of the efficacy rate difference between the two groups was -7.5~9.1%, the clinical equivalency (non-inferiority) of the pazufloxacin mesilate group to the CAZ group was demonstrated at Δ=10%. Although significant bias was found between the two groups in the patient background factors concerning 'sex', 'concomitant drugs', 'body temperature', 'ESR', 'CRP', and 'chest X-ray findings', clinical equivalency of the pazufloxacin mesilate group to the CAZ group was conclued after correction for these biases too. 3. Among the cases evaluated for clinical efficacy, 85 cases in which the causative organisms were isolated were evaluated for bacteriological effects. The bacteriological eradication rate was 81.1% (30/37) in the pazufloxacin mesilate group and 100% (48/48) in the CAZ group, and the difference between the two groups was statistically significant (p=0.002, Fisher's exact probability method). 4. The incidence of adverse effects was 5.5% (6/110) in the pazufloxacin mesilate group and 7.8% (9/115) in the CAZ group, and the difference between the groups was not significant. The incidence of abnormal laboratory findings was 31.0% (31/100) in the pazufloxacin mesilate group and 29.6% (32/108) in the CAZ group, and the difference between the groups was not significant. None of the adverse effects were serious. 5. The safety rate was 65.3% (66/101) in the pazufloxacin mesilate group and 62.4% (68/109) in the CAZ group, and the difference between the groups was not significant. 6. The usefulness rate was 86.6% (71/82) in the pazufloxacin mesilate group and 82.0% (82/100) in the CAZ group, and the difference between the groups was not significant. These findings indicate that pazufloxacin mesilate is one of the most effective drugs for bacterial pneumonia.

    Original languageEnglish
    Pages (from-to)433-463
    Number of pages31
    JournalJapanese Journal of Chemotherapy
    Volume48
    Issue number6
    Publication statusPublished - 2000 Jan 1

    Keywords

    • Ceftazidime
    • Pazufloxacin

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)

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  • Cite this

    Shimada, K., Abe, S., Fujishima, T., Honma, A., Shirato, K., Ohno, I., Takahashi, M., Ishii, M., Maeda, S., Sakamoto, M., Konishi, K., Nukiwa, T., Watanabe, A., Nagai, K., Takeda, H., Osonoi, T., Kobayashi, H., Kawai, S., Hosoya, T., ... Shimazu, K. (2000). Clinical evaluation of pazufloxacin mesilate for bacterial pneumonia: Phase III comparative study of pazufloxacin mesilate versus ceftazidime. Japanese Journal of Chemotherapy, 48(6), 433-463.