An early phase II study on FK 037 in urinary tract infections
The clinical efficacy and safety of FK 037, a new parenteral cephem antibiotic, in patients with urinary tract infections (UTI) were preliminarily evaluated.The subjects consisted of inpatients, aged 15 to 79 years, with complicated UTI, underlying urinary tract diseases and no indwelling catheter.T...
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| Published in | CHEMOTHERAPY Vol. 42; no. 9; pp. 1036 - 1047 |
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| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English Japanese |
| Published |
Japanese Society of Chemotherapy
1994
公益社団法人 日本化学療法学会 |
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| Online Access | Get full text |
| ISSN | 0009-3165 1884-5894 |
| DOI | 10.11250/chemotherapy1953.42.1036 |
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| Abstract | The clinical efficacy and safety of FK 037, a new parenteral cephem antibiotic, in patients with urinary tract infections (UTI) were preliminarily evaluated.The subjects consisted of inpatients, aged 15 to 79 years, with complicated UTI, underlying urinary tract diseases and no indwelling catheter.The drug was intravenously infused at doses of 0.5, 1.0 and 2.0 g (potency), twice daily (in the morning and evening), for 5 to 9 days.Clinical efficacy was evaluated using the criteria proposed by the Japanese UTI Committee.Of 32 patients who met the inclusion criteria, the overall clinical efficacy of FK 037 was “excellent” in 15 patients, “moderate”in 15 and “poor” in 2, an efficacy rate of 93.8%.Only 1 patient showed a clinical adverse reaction (rash), and only 1 patient showed a laboratory adverse reaction (mild increase in GPT).These results showed that FK 037 provided a good clinical effect, reflecting its activity against a wide range of gram-positive and gram-negative organisms, and that the drug might present no significant problems concerning safety.This drug, therefore, could be useful for the treatment of UTI. |
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| AbstractList | The clinical efficacy and safety of FK 037, a new parenteral cephem antibiotic, in patients with urinary tract infections (UTI) were preliminarily evaluated.The subjects consisted of inpatients, aged 15 to 79 years, with complicated UTI, underlying urinary tract diseases and no indwelling catheter.The drug was intravenously infused at doses of 0.5, 1.0 and 2.0 g (potency), twice daily (in the morning and evening), for 5 to 9 days.Clinical efficacy was evaluated using the criteria proposed by the Japanese UTI Committee.Of 32 patients who met the inclusion criteria, the overall clinical efficacy of FK 037 was “excellent” in 15 patients, “moderate”in 15 and “poor” in 2, an efficacy rate of 93.8%.Only 1 patient showed a clinical adverse reaction (rash), and only 1 patient showed a laboratory adverse reaction (mild increase in GPT).These results showed that FK 037 provided a good clinical effect, reflecting its activity against a wide range of gram-positive and gram-negative organisms, and that the drug might present no significant problems concerning safety.This drug, therefore, could be useful for the treatment of UTI. The clinical efficacy and safety of FK 037, a new parenteral cephem antibiotic, in patients with urinary tract infections (UTI) were preliminarily evaluated.The subjects consisted of inpatients, aged 15 to 79 years, with complicated UTI, underlying urinary tract diseases and no indwelling catheter.The drug was intravenously infused at doses of 0.5, 1.0 and 2.0 g (potency), twice daily (in the morning and evening), for 5 to 9 days.Clinical efficacy was evaluated using the criteria proposed by the Japanese UTI Committee.Of 32 patients who met the inclusion criteria, the overall clinical efficacy of FK 037 was “excellent” in 15 patients, “moderate”in 15 and “poor” in 2, an efficacy rate of 93.8%.Only 1 patient showed a clinical adverse reaction (rash), and only 1 patient showed a laboratory adverse reaction (mild increase in GPT).These results showed that FK 037 provided a good clinical effect, reflecting its activity against a wide range of gram-positive and gram-negative organisms, and that the drug might present no significant problems concerning safety.This drug, therefore, could be useful for the treatment of UTI. 新しい注射用セフェム剤FK 037の泌尿器科領域感染症に対する臨床効果と安全性を予備的に検討した。対象は尿路に基礎疾患を有するカテーテル非留置の複雑性尿路感染症で, 15歳以上80歳未満の入院患者とした。用法・用量は1回0.5g (力価), 1.0g (力価) または2.0g (力価) を朝・夕の1日2回, 5～9日間点滴静注し, UTI薬効評価基準に従い臨床効果を判定した。UTI薬効評価基準に合致した32例における臨床効果は著効15例, 有効15例, 無効2例で有効率は93.8%であった。副作用は1例に発疹がみられ, 臨床検査値の異常変動は1例に軽度のGPT上昇が認められたのみであった。以上の成績から, 本剤はグラム陽性菌からグラム陰性菌まで幅広い抗菌スペクトルを有しており, これを反映して臨床試験においても優れた効果を示し, 安全性も特に問題がないことから, 泌尿器科領域感染症に対して有用性が期待される薬剤であると考えられる。 |
| Author | Saito, Isao Kawamura, Nobuo Kawada, Yukimichi Ohmori, Hiroyuki Kumamoto, Yoshiaki Kumazawa, Joichi Kamidono, Sadao |
| Author_FL | 斎藤 功 守殿 貞夫 河田 幸道 熊澤 淨一 河村 信夫 大森 弘之 熊本 悦明 |
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| Author_xml | – sequence: 1 fullname: Kawamura, Nobuo organization: Department of Urology, School of Medicine, Tokai University – sequence: 1 fullname: Ohmori, Hiroyuki organization: Department of Urology, Okayama University, Medical School – sequence: 1 fullname: Saito, Isao organization: Department of Urology, Tokyo Kyosai Hospital – sequence: 1 fullname: Kamidono, Sadao organization: Department of Urology, Kobe University, School of Medicine – sequence: 1 fullname: Kawada, Yukimichi organization: Department of Urology, Gifu University School of Medicine – sequence: 1 fullname: Kumazawa, Joichi organization: Department of Urology, Faculty of Medicine, Kyushu University – sequence: 1 fullname: Kumamoto, Yoshiaki organization: Department of Urology, School of Medicine, Sapporo Medical University |
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| References | 4) Mine Y, et al.: In vivo antibacterial activity of FK 037, a novel parenteral broad-spectrum cephalosporin. J Antibiot 46: 88-98, 1993 21) Naide Y, et al.: Comparative study of cefpirome and ceftazidime in complicated urinary tract infections. Acta Urologica Japonica 37: 447-464, 1991 (in Japanese 16) Matsumoto T, Kumazawa J: Evaluation of drug efficacy for catheterized patients. Antibiot & Chemother 6: 2137-2144, 1990 (in Japanese 1) Mine, Y, et al.: In vitro antibacterial activity of FK 037, a novel parenteral broad-spectrum cephalosporin. J Antibiot 46: 71-87, 1993 9) Yokota T, Suzuki E: A new, improved parenteral cephem antibiotic-FK 037, its in vitro antibacterial activity. Program and Abstracts No.853, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 2) Ohki H, Kawabata K, Okuda S, Kamimura T, Sakane K: FK 037, a new parenteral cephalosporin with a broad antibacterial spectrum. J Antibiot 46: 359-361, 1993 8) Mine Y, Sakamoto H, Hatano K, Higashi Y, Kamimura T, Matsumoto F, Kuwahara S: FK 037, a novel parenteral broad-spectrum cephalosporin: IV. Animal pharmacokinetics Program and Abstracts No.852, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 22) Kumazawa J, et al.: Dose-finding study of cefe. pime for the treatment of complicated urinary tract infections. Nishinihon J Urol 54: 285-298, 1992 (in Japanese 5) Mine Y, Watanabe Y, Sakamoto H, Hatano K, Kamimura T, Matsumoto F, Kuwahara S: FK 037, A novel parenteral broad-spectrum cephalosporin: I. In vitro antibacterial activity. Program and Abstracts No.849, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 20) Naide Y, et al.: Dose-finding study of HR810 (cefpirome) in complicated urinary tract infections. Chemotherapy (Tokyo) 39: 158-173, 1991 (in Javanese 25) Kumazawa J, et al.: Comparative study of cefclidin and ceftazidime for the treatment of complicated urinary tract infections. Nishinihon J Urol 54: 1435-1460, 1992 (in Japanese 3) Mine, Y, et al.: Excellent activity of FK 037, a novel parenteral broad-spectrum cephalosporin, against methicillin-resistant staphylococci. J Antibiot 46: 99-119, 1993 24) Kumazawa J, et al.: Clinical evaluation of cefclidin for the treatment of complicated urinary tract infections.-Dote-finding study using ceftazidime as a reference drug-.Nishinihon J Urol 54: 528-549, 1992 (in Japanese 12) Goto S, Higashi 5, Miyazaki S, Kaneko Y, Yamaguchi K: FK 037, a New Parenteral Cephalosporin: In vitro and in vivo antibacterial activity. Program and Abstracts No.856, 31 at Interscience Conference on Antimicrobial Agents and Chemotherapy, 1991 15) Nakashima M, Uematsu T, Takiguchi Y, Obara M, Terakawa M: Pharmacokinetics and safety of FK 037 in healthy volunteers. Program and Abstracts, No.883, 33 rd Interscience Conference on Antimicrobial Agents and Chemotherapy, New Orleans, 1993 6) Mine Y, Watanabe Y, Sakamoto H, Kamimura T, Tawara S, Matsumoto F, Kuwahara S. FK 037, a novel parenteral broad-spectrum cephalosporin: II. In vivo antibacterial activity. Program and Abstracts No.850, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 23) Kumazawa J, et al.: Comparative study of cefepime vs ceftazidime for the treatment of complicated urinary tract infections. Nishinihon J Urol 54: 974-985, 1992 (in Japanese 13) Nishino T, Otsuki M, Nishihara Y: In vitro and in vivo antibacterial activities of FK 037, a new broad-spectrum cephalosporin. Program and Abstracts No.857, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 18) UTI Committee (Chairman: Ohkoshi M): Criteria for evaluation of clinical efficacy of antimicrobial agents on urinary tract infection (Third edition). Chemotherapy (Tokyo) 34: 408-441, 1986 (in Japanese 10) Inoue K, Hamana Y, Mitsuhashi S: In vitro antibacterial activity of FK 037, a new cephalosporin. Program and Abstracts No.854, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 11) Ueno K, Watanabe K, Kato N, Muto Y, Bandoh K, Oka M: Comparative in vitro activity of FK 037, a novel cephalosporin, and other related agents against anaerobic bacteria. Program and Abstracts No.855, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 19) Deputy Director, New Drugs Division Pharmaceutical Affairs Bureau Ministry of Health & Welfare Japan: General consideration for the clinical evaluation of new drugs. Clin Eval 20: 401-411, 1992 (in Japanese 7) Mine Y, Watanabe Y, Sakamoto H, Kamimura T, Matsumoto F, Kuwahara S: FK 037, A novel parenteral broad-spectrum cephalosporin: III. Excellent activity against methicillin-resistant Staphylococci. Program and Abstracts No.851, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 17) Japan Society of Chemotherapy: A method for determining the minimum inhibitory concentration of antimicrobial agents (3 rd edition). Chemotherapy (Tokyo) 29: 76-79, 1981 (in Japanese 14) FK 037 Toxicology Studies-The Reports of Fujisawa Pharmaceutical Co. Ltd. |
| References_xml | – reference: 1) Mine, Y, et al.: In vitro antibacterial activity of FK 037, a novel parenteral broad-spectrum cephalosporin. J Antibiot 46: 71-87, 1993 – reference: 13) Nishino T, Otsuki M, Nishihara Y: In vitro and in vivo antibacterial activities of FK 037, a new broad-spectrum cephalosporin. Program and Abstracts No.857, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 – reference: 4) Mine Y, et al.: In vivo antibacterial activity of FK 037, a novel parenteral broad-spectrum cephalosporin. J Antibiot 46: 88-98, 1993 – reference: 8) Mine Y, Sakamoto H, Hatano K, Higashi Y, Kamimura T, Matsumoto F, Kuwahara S: FK 037, a novel parenteral broad-spectrum cephalosporin: IV. Animal pharmacokinetics Program and Abstracts No.852, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 – reference: 24) Kumazawa J, et al.: Clinical evaluation of cefclidin for the treatment of complicated urinary tract infections.-Dote-finding study using ceftazidime as a reference drug-.Nishinihon J Urol 54: 528-549, 1992 (in Japanese) – reference: 21) Naide Y, et al.: Comparative study of cefpirome and ceftazidime in complicated urinary tract infections. Acta Urologica Japonica 37: 447-464, 1991 (in Japanese) – reference: 14) FK 037 Toxicology Studies-The Reports of Fujisawa Pharmaceutical Co. Ltd. – reference: 18) UTI Committee (Chairman: Ohkoshi M): Criteria for evaluation of clinical efficacy of antimicrobial agents on urinary tract infection (Third edition). Chemotherapy (Tokyo) 34: 408-441, 1986 (in Japanese) – reference: 16) Matsumoto T, Kumazawa J: Evaluation of drug efficacy for catheterized patients. Antibiot & Chemother 6: 2137-2144, 1990 (in Japanese) – reference: 7) Mine Y, Watanabe Y, Sakamoto H, Kamimura T, Matsumoto F, Kuwahara S: FK 037, A novel parenteral broad-spectrum cephalosporin: III. Excellent activity against methicillin-resistant Staphylococci. Program and Abstracts No.851, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 – reference: 9) Yokota T, Suzuki E: A new, improved parenteral cephem antibiotic-FK 037, its in vitro antibacterial activity. Program and Abstracts No.853, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 – reference: 12) Goto S, Higashi 5, Miyazaki S, Kaneko Y, Yamaguchi K: FK 037, a New Parenteral Cephalosporin: In vitro and in vivo antibacterial activity. Program and Abstracts No.856, 31 at Interscience Conference on Antimicrobial Agents and Chemotherapy, 1991 – reference: 22) Kumazawa J, et al.: Dose-finding study of cefe. pime for the treatment of complicated urinary tract infections. Nishinihon J Urol 54: 285-298, 1992 (in Japanese) – reference: 20) Naide Y, et al.: Dose-finding study of HR810 (cefpirome) in complicated urinary tract infections. Chemotherapy (Tokyo) 39: 158-173, 1991 (in Javanese) – reference: 6) Mine Y, Watanabe Y, Sakamoto H, Kamimura T, Tawara S, Matsumoto F, Kuwahara S. FK 037, a novel parenteral broad-spectrum cephalosporin: II. In vivo antibacterial activity. Program and Abstracts No.850, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 – reference: 17) Japan Society of Chemotherapy: A method for determining the minimum inhibitory concentration of antimicrobial agents (3 rd edition). Chemotherapy (Tokyo) 29: 76-79, 1981 (in Japanese) – reference: 11) Ueno K, Watanabe K, Kato N, Muto Y, Bandoh K, Oka M: Comparative in vitro activity of FK 037, a novel cephalosporin, and other related agents against anaerobic bacteria. Program and Abstracts No.855, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 – reference: 5) Mine Y, Watanabe Y, Sakamoto H, Hatano K, Kamimura T, Matsumoto F, Kuwahara S: FK 037, A novel parenteral broad-spectrum cephalosporin: I. In vitro antibacterial activity. Program and Abstracts No.849, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 – reference: 10) Inoue K, Hamana Y, Mitsuhashi S: In vitro antibacterial activity of FK 037, a new cephalosporin. Program and Abstracts No.854, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991 – reference: 15) Nakashima M, Uematsu T, Takiguchi Y, Obara M, Terakawa M: Pharmacokinetics and safety of FK 037 in healthy volunteers. Program and Abstracts, No.883, 33 rd Interscience Conference on Antimicrobial Agents and Chemotherapy, New Orleans, 1993 – reference: 2) Ohki H, Kawabata K, Okuda S, Kamimura T, Sakane K: FK 037, a new parenteral cephalosporin with a broad antibacterial spectrum. J Antibiot 46: 359-361, 1993 – reference: 23) Kumazawa J, et al.: Comparative study of cefepime vs ceftazidime for the treatment of complicated urinary tract infections. Nishinihon J Urol 54: 974-985, 1992 (in Japanese) – reference: 19) Deputy Director, New Drugs Division Pharmaceutical Affairs Bureau Ministry of Health & Welfare Japan: General consideration for the clinical evaluation of new drugs. Clin Eval 20: 401-411, 1992 (in Japanese) – reference: 25) Kumazawa J, et al.: Comparative study of cefclidin and ceftazidime for the treatment of complicated urinary tract infections. Nishinihon J Urol 54: 1435-1460, 1992 (in Japanese) – reference: 3) Mine, Y, et al.: Excellent activity of FK 037, a novel parenteral broad-spectrum cephalosporin, against methicillin-resistant staphylococci. J Antibiot 46: 99-119, 1993 |
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| Title | An early phase II study on FK 037 in urinary tract infections |
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