An early phase II study of FK 037 for respiratory tract infections

Rinzo Soejima; Yoshihito Niki; Niro Okimoto; Osamu Moriya; Masaru Sumi; Akira Saito; Ichiro Nakayama; Masumi Tomizawa; Akira Watanabe; Yutaka Tokue; Shigeo Takizawa; Mikae Nakamura; Kohya Shiba; Osamu Sakai; Atsushi Saito; Kaoru Shimada; Takashi Inamatsu; Hiroyuki Kobayashi; Seiji Hori; Jingoro Shimada; Fumio Matsumoto; Takeo Imai; Kouji Yoshikawa; Fumio Miki; Toshiharu Matsushima; Makoto Kimura; Kotaro Oizumi; Yoichiro Ichikawa; Naoto Tokunaga; Kohei Hara; Shigeru Kohno; Hironobu Koga; Mitsuo Kaku; Kazunori Tomono; Sadahiro Asai; Naofumi Suyama; Jun Araki; Hideo Mashimoto; Rokushi Oka; Tatsuya Katsumata; Keizo Matsumoto; Hiroshi Watanabe; Akemi Ohmori; Moritoshi Akiyama; Yoshiaki Utsunomiya; Kazunori Ooishi; Tsuyoshi Nagatake; Atsushi Saito; Jun Inatome; Hiroshi Fukuhara

doi:10.11250/chemotherapy1953.42.1128

An early phase II study of FK 037 for respiratory tract infections

Rinzo Soejima, Yoshihito Niki, Niro Okimoto, Osamu Moriya, Masaru Sumi, Akira Saito, Ichiro Nakayama, Masumi Tomizawa, Akira Watanabe, Yutaka Tokue, Shigeo Takizawa, Mikae Nakamura, Kohya Shiba, Osamu Sakai, Atsushi Saito, Kaoru Shimada, Takashi Inamatsu, Hiroyuki Kobayashi, Seiji Hori, Jingoro ShimadaFumio Matsumoto, Takeo Imai, Kouji Yoshikawa, Fumio Miki, Toshiharu Matsushima, Makoto Kimura, Kotaro Oizumi, Yoichiro Ichikawa, Naoto Tokunaga, Kohei Hara, Shigeru Kohno, Hironobu Koga, Mitsuo Kaku, Kazunori Tomono, Sadahiro Asai, Naofumi Suyama, Jun Araki, Hideo Mashimoto, Rokushi Oka, Tatsuya Katsumata, Keizo Matsumoto, Hiroshi Watanabe, Akemi Ohmori, Moritoshi Akiyama, Yoshiaki Utsunomiya, Kazunori Ooishi, Tsuyoshi Nagatake, Atsushi Saito, Jun Inatome, Hiroshi Fukuhara

Research output: Contribution to journal › Article › peer-review

13 Citations (Scopus)

Abstract

An early phase II trial of FK 037, a parenteral cephalosporin, was conducted in patients with respiratory tract infections. 1) The efficacy, safety and usefulness of FK 037 were evaluated in 41 patients with respiratory tract infections who were intravenously infused with the drug at a dose of 0.5, 1.0 or 2.0 g, twice daily, for 3 to 14 days, as a rule. 2) Efficacy in 39 patients who were evaluable (26 with pneumonia, 8 with chronic respiratory tract infections, 3 with pyothorax or pleurisy, and 2 with acute bronchitis), was “excellent” in 15 and “good” in 19, an efficacy rate of 87.2%. The efficacy rates by dosage were 91.7% (11/12), 100% (19/19) and 66%(4/6) at 0.5 g b. i. d., 1.0 g b. i. d. and 2.0 g b. i. d., respectively. 3) All of 9 strains of Streptococcus pneumoniae, 7 strains of Haemophilus influenzae and 2 strains of Pseudomonas aeruginosa were eradicated by FK 037 dosing. Of 27 bacterial strains detected, 25 strains (92.6%) were eradicated. 4) No side effects were seen. Abnormal changes in laboratory tests were noted in 12 (30.0%) out of 40 patients who were evaluated for safety. These were mostly mild increases in hepatic enzyme levels, and there were no cases associated with clinical signs or serious cases. 5) The drug was rated “remarkably useful” in 10, of 38 evaluable patients, “useful” in 23, “slightly useful” in 2 and “not useful” in 3, a usefulness rate of 86.8%. These results suggest that FK 037 can be given with good results at clinical doses of 0.5 g b. i. d., 1.0 g b. i. d. and 2.0 g b. i. d.

Original language	English
Pages (from-to)	1128-1142
Number of pages	15
Journal	Chemotherapy
Volume	42
Issue number	10
DOIs	https://doi.org/10.11250/chemotherapy1953.42.1128
Publication status	Published - 1994
Externally published	Yes

Keywords

FK 037
clinical study
early phase II trial
infections in internal medicine
respiratory tract infections

ASJC Scopus subject areas

Pharmacology (medical)
Infectious Diseases
Pharmacology
Drug Discovery
Oncology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.11250/chemotherapy1953.42.1128

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Soejima, R., Niki, Y., Okimoto, N., Moriya, O., Sumi, M., Saito, A., Nakayama, I., Tomizawa, M., Watanabe, A., Tokue, Y., Takizawa, S., Nakamura, M., Shiba, K., Sakai, O., Saito, A., Shimada, K., Inamatsu, T., Kobayashi, H., Hori, S., ... Fukuhara, H. (1994). An early phase II study of FK 037 for respiratory tract infections. Chemotherapy, 42(10), 1128-1142. https://doi.org/10.11250/chemotherapy1953.42.1128

Soejima, R, Niki, Y, Okimoto, N, Moriya, O, Sumi, M, Saito, A, Nakayama, I, Tomizawa, M, Watanabe, A, Tokue, Y, Takizawa, S, Nakamura, M, Shiba, K, Sakai, O, Saito, A, Shimada, K, Inamatsu, T, Kobayashi, H, Hori, S, Shimada, J, Matsumoto, F, Imai, T, Yoshikawa, K, Miki, F, Matsushima, T, Kimura, M, Oizumi, K, Ichikawa, Y, Tokunaga, N, Hara, K, Kohno, S, Koga, H, Kaku, M, Tomono, K, Asai, S, Suyama, N, Araki, J, Mashimoto, H, Oka, R, Katsumata, T, Matsumoto, K, Watanabe, H, Ohmori, A, Akiyama, M, Utsunomiya, Y, Ooishi, K, Nagatake, T, Saito, A, Inatome, J & Fukuhara, H 1994, 'An early phase II study of FK 037 for respiratory tract infections', Chemotherapy, vol. 42, no. 10, pp. 1128-1142. https://doi.org/10.11250/chemotherapy1953.42.1128

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title = "An early phase II study of FK 037 for respiratory tract infections",

abstract = "An early phase II trial of FK 037, a parenteral cephalosporin, was conducted in patients with respiratory tract infections. 1) The efficacy, safety and usefulness of FK 037 were evaluated in 41 patients with respiratory tract infections who were intravenously infused with the drug at a dose of 0.5, 1.0 or 2.0 g, twice daily, for 3 to 14 days, as a rule. 2) Efficacy in 39 patients who were evaluable (26 with pneumonia, 8 with chronic respiratory tract infections, 3 with pyothorax or pleurisy, and 2 with acute bronchitis), was “excellent” in 15 and “good” in 19, an efficacy rate of 87.2%. The efficacy rates by dosage were 91.7% (11/12), 100% (19/19) and 66%(4/6) at 0.5 g b. i. d., 1.0 g b. i. d. and 2.0 g b. i. d., respectively. 3) All of 9 strains of Streptococcus pneumoniae, 7 strains of Haemophilus influenzae and 2 strains of Pseudomonas aeruginosa were eradicated by FK 037 dosing. Of 27 bacterial strains detected, 25 strains (92.6%) were eradicated. 4) No side effects were seen. Abnormal changes in laboratory tests were noted in 12 (30.0%) out of 40 patients who were evaluated for safety. These were mostly mild increases in hepatic enzyme levels, and there were no cases associated with clinical signs or serious cases. 5) The drug was rated “remarkably useful” in 10, of 38 evaluable patients, “useful” in 23, “slightly useful” in 2 and “not useful” in 3, a usefulness rate of 86.8%. These results suggest that FK 037 can be given with good results at clinical doses of 0.5 g b. i. d., 1.0 g b. i. d. and 2.0 g b. i. d.",

keywords = "FK 037, clinical study, early phase II trial, infections in internal medicine, respiratory tract infections",

author = "Rinzo Soejima and Yoshihito Niki and Niro Okimoto and Osamu Moriya and Masaru Sumi and Akira Saito and Ichiro Nakayama and Masumi Tomizawa and Akira Watanabe and Yutaka Tokue and Shigeo Takizawa and Mikae Nakamura and Kohya Shiba and Osamu Sakai and Atsushi Saito and Kaoru Shimada and Takashi Inamatsu and Hiroyuki Kobayashi and Seiji Hori and Jingoro Shimada and Fumio Matsumoto and Takeo Imai and Kouji Yoshikawa and Fumio Miki and Toshiharu Matsushima and Makoto Kimura and Kotaro Oizumi and Yoichiro Ichikawa and Naoto Tokunaga and Kohei Hara and Shigeru Kohno and Hironobu Koga and Mitsuo Kaku and Kazunori Tomono and Sadahiro Asai and Naofumi Suyama and Jun Araki and Hideo Mashimoto and Rokushi Oka and Tatsuya Katsumata and Keizo Matsumoto and Hiroshi Watanabe and Akemi Ohmori and Moritoshi Akiyama and Yoshiaki Utsunomiya and Kazunori Ooishi and Tsuyoshi Nagatake and Atsushi Saito and Jun Inatome and Hiroshi Fukuhara",

year = "1994",

doi = "10.11250/chemotherapy1953.42.1128",

language = "English",

volume = "42",

pages = "1128--1142",

journal = "CHEMOTHERAPY",

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T1 - An early phase II study of FK 037 for respiratory tract infections

AU - Soejima, Rinzo

AU - Niki, Yoshihito

AU - Okimoto, Niro

AU - Moriya, Osamu

AU - Sumi, Masaru

AU - Saito, Akira

AU - Nakayama, Ichiro

AU - Tomizawa, Masumi

AU - Watanabe, Akira

AU - Tokue, Yutaka

AU - Takizawa, Shigeo

AU - Nakamura, Mikae

AU - Shiba, Kohya

AU - Sakai, Osamu

AU - Saito, Atsushi

AU - Shimada, Kaoru

AU - Inamatsu, Takashi

AU - Kobayashi, Hiroyuki

AU - Hori, Seiji

AU - Shimada, Jingoro

AU - Matsumoto, Fumio

AU - Imai, Takeo

AU - Yoshikawa, Kouji

AU - Miki, Fumio

AU - Matsushima, Toshiharu

AU - Kimura, Makoto

AU - Oizumi, Kotaro

AU - Ichikawa, Yoichiro

AU - Tokunaga, Naoto

AU - Hara, Kohei

AU - Kohno, Shigeru

AU - Koga, Hironobu

AU - Kaku, Mitsuo

AU - Tomono, Kazunori

AU - Asai, Sadahiro

AU - Suyama, Naofumi

AU - Araki, Jun

AU - Mashimoto, Hideo

AU - Oka, Rokushi

AU - Katsumata, Tatsuya

AU - Matsumoto, Keizo

AU - Watanabe, Hiroshi

AU - Ohmori, Akemi

AU - Akiyama, Moritoshi

AU - Utsunomiya, Yoshiaki

AU - Ooishi, Kazunori

AU - Nagatake, Tsuyoshi

AU - Saito, Atsushi

AU - Inatome, Jun

AU - Fukuhara, Hiroshi

PY - 1994

Y1 - 1994

N2 - An early phase II trial of FK 037, a parenteral cephalosporin, was conducted in patients with respiratory tract infections. 1) The efficacy, safety and usefulness of FK 037 were evaluated in 41 patients with respiratory tract infections who were intravenously infused with the drug at a dose of 0.5, 1.0 or 2.0 g, twice daily, for 3 to 14 days, as a rule. 2) Efficacy in 39 patients who were evaluable (26 with pneumonia, 8 with chronic respiratory tract infections, 3 with pyothorax or pleurisy, and 2 with acute bronchitis), was “excellent” in 15 and “good” in 19, an efficacy rate of 87.2%. The efficacy rates by dosage were 91.7% (11/12), 100% (19/19) and 66%(4/6) at 0.5 g b. i. d., 1.0 g b. i. d. and 2.0 g b. i. d., respectively. 3) All of 9 strains of Streptococcus pneumoniae, 7 strains of Haemophilus influenzae and 2 strains of Pseudomonas aeruginosa were eradicated by FK 037 dosing. Of 27 bacterial strains detected, 25 strains (92.6%) were eradicated. 4) No side effects were seen. Abnormal changes in laboratory tests were noted in 12 (30.0%) out of 40 patients who were evaluated for safety. These were mostly mild increases in hepatic enzyme levels, and there were no cases associated with clinical signs or serious cases. 5) The drug was rated “remarkably useful” in 10, of 38 evaluable patients, “useful” in 23, “slightly useful” in 2 and “not useful” in 3, a usefulness rate of 86.8%. These results suggest that FK 037 can be given with good results at clinical doses of 0.5 g b. i. d., 1.0 g b. i. d. and 2.0 g b. i. d.

AB - An early phase II trial of FK 037, a parenteral cephalosporin, was conducted in patients with respiratory tract infections. 1) The efficacy, safety and usefulness of FK 037 were evaluated in 41 patients with respiratory tract infections who were intravenously infused with the drug at a dose of 0.5, 1.0 or 2.0 g, twice daily, for 3 to 14 days, as a rule. 2) Efficacy in 39 patients who were evaluable (26 with pneumonia, 8 with chronic respiratory tract infections, 3 with pyothorax or pleurisy, and 2 with acute bronchitis), was “excellent” in 15 and “good” in 19, an efficacy rate of 87.2%. The efficacy rates by dosage were 91.7% (11/12), 100% (19/19) and 66%(4/6) at 0.5 g b. i. d., 1.0 g b. i. d. and 2.0 g b. i. d., respectively. 3) All of 9 strains of Streptococcus pneumoniae, 7 strains of Haemophilus influenzae and 2 strains of Pseudomonas aeruginosa were eradicated by FK 037 dosing. Of 27 bacterial strains detected, 25 strains (92.6%) were eradicated. 4) No side effects were seen. Abnormal changes in laboratory tests were noted in 12 (30.0%) out of 40 patients who were evaluated for safety. These were mostly mild increases in hepatic enzyme levels, and there were no cases associated with clinical signs or serious cases. 5) The drug was rated “remarkably useful” in 10, of 38 evaluable patients, “useful” in 23, “slightly useful” in 2 and “not useful” in 3, a usefulness rate of 86.8%. These results suggest that FK 037 can be given with good results at clinical doses of 0.5 g b. i. d., 1.0 g b. i. d. and 2.0 g b. i. d.

KW - FK 037

KW - clinical study

KW - early phase II trial

KW - infections in internal medicine

KW - respiratory tract infections

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An early phase II study of FK 037 for respiratory tract infections

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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