Clinical evaluation of ciprofloxacin for bacterial pneumonia -phase III comparative study of intravenous ciprofloxacin versus ceftazidime

Kohei Hara, Shigeru Kohno, Jun Ichi Kadota, Kazunori Tomono, Yoichi Hirakata, Shigefumi Maesaki, Masao Nakatomi, Sadahiro Asai, Ryusuke Mizukane, Kazuhiro Okuno, Kiyoyasu Fukushima, Naomi Itoh, Yuichi Inoue, Takao Koike, Katsunori Onishi, Mitsuhide Omichi, Gen Yamada, Yomei Hiraga, Akira Watanabe, Toshihiro NukiwaKenichi Takeuchi, Kazunao Niizuma, Kenji Yanase, Hitonobu Tomoike, Hidenori Nakamura, Shuichi Kato, Makoto Sata, Hideki Ikeda, Miyoko Itasaka, Masaaki Arakawa, Kouichi Wada, Michihiko Haraguchi, Shigeyuki Hoshino, Kenichi Igarashi, Yoshinori Shimazu, Yukiyoshi Kon, Hiroyuki Sega, Osamu Sekine, Yasutoshi Suzuki, Nobuki Aoki, Takao Takizawa, Toshinori Kanemura, Hisashi Takemura, Kohshu Nagao, Yoshio Hamashima, Yoshio Sakamoto, Kenji Sakata, Takeo Toyoda, Mitsuhiko Ohsumi, Hiroyuki Kobayashi, Shin Kawai, Susumu Sakayori, Hiroshi Sugiura, Hiroshi Oshitani, Kaoru Shimada, Yasuyuki Sano, Yasuo Arai, Takako Hojo, Chuhei Ogawa, Kohya Shiba, Masaki Yoshida, Kazuhisa Okada, Tetsuo Sato, Futoshi Kotajima, Izumi Hayashi, Harumi Shishido, Fumio Matsumoto, Iwao Sakurai, Shigeki Odagiri, Kaneo Suzuki, Yuji Watanuki, Kenichi Takahashi, Yasuhiro Yoshiike, Toshiyuki Yamamoto, Kanzo Suzuki, Kaoru Shimokata, Atsushi Kawabata, Yoshinori Hasegawa, Hidehiko Saito, Shuzo Sakai, Keisuke Nishiwaki, Masashi Yamamoto, Tomohiko Ogasawara, Masamitsu Iwata, Hiroshi Saito, Fumio Miki, Nobuhiro Narita, Keiichi Mikasa, Yoshihito Niki, Satoru Kawabata, Toshiharu Matsushima, Rinzo Soejima, Yoshiro Sawae, Koji Takaki, Kotaro Oizumi, Shouji Kinoshita, Yoshiyuki Mitsutake, Masashi Kawahara, Keisuke Takeda

    Research output: Contribution to journalArticlepeer-review

    2 Citations (Scopus)

    Abstract

    We compared intravenously administered ciprofloxacin (CPFX) with ceftazidime (CAZ) in a randomized, well-controlled manner in terms of clinical efficacy, safety and usefulness. Patients with moderate to severe bacterial pneumonia received either CPFX 300 mg b.i.d. or CAZ 2 g b.i.d. intravenously for 14 days. The following results were obtained in this trial: 1. A total of 201 patients were enrolled in this study. The cases évaluable for clinical efficacy, safety and usefulness were 91, 98 and 95 in the CPFX group, and 75, 87 and 80 in the CAZ group, respectively. Although a statistical bias was found in the severity of infections, it had no effect on the evaluation of clinical efficacy. 2. The clinical efficacy rate was 85.7% (78/91) in the CPFX group and 84.0% (63/75) in the CAZ group. There was no statistically significant difference between the two groups, and the statistical equivalence between them was shown at A = 10%. 3. The elimination rate of causative organisms was 78.9% (30/38) in the CPFX group and 100% (28/28) in the CAZ group. Statistical significance was demonstrated between these values (p = 0.017, Fisher's exact test). 4. Side effects were noted in 11.1% (11/99) in the CPFX group and 13.8% (12/87) in the CAZ group. The major events were local reactions at injection sites, hypersensitivity symptoms and central nervous system disorders. 5. Abnormal laboratory findings were detected in 22.3% (21/94) in the CPFX group and 29.4% (25/85) in the CAZ group. The major events were eosinophilia and elevation of transaminases. 6. The safety rate was 70.4% (69/98) in the CPFX group and 63.2% (55/87) in the CAZ group. There was no significant difference between these values. 7. The ratios judged as better than useful in the CPFX and CAZ groups were 76.8% (73/95) and 77.2% (61/80), respectively, not significantly different. These results indicate that CPFX is a highly effective drug for the treatment of bacterial pneumonia.

    Original languageEnglish
    Pages (from-to)920-922
    Number of pages3
    JournalJapanese Journal of Chemotherapy
    Volume45
    Issue number11
    Publication statusPublished - 1997

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)

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