An early phase II study on FK 037 in urinary tract infections

• Published in: CHEMOTHERAPY Vol. 42; no. 9; pp. 1036 - 1047
• Main Authors: Kawamura, Nobuo, Ohmori, Hiroyuki, Saito, Isao, Kamidono, Sadao, Kawada, Yukimichi, Kumazawa, Joichi, Kumamoto, Yoshiaki
• 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
• Subjects: early phase II study; FK 037; urinary tract infections
• ISSN: 0009-3165; 1884-5894
• DOI: 10.11250/chemotherapy1953.42.1036

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.