Clinical studies of NM441 in complicated urinary tract infections On the utility and recurrence after 14-day streatment

• Published in: Japanese Journal of Chemotherapy Vol. 44; no. Supplement1; pp. 420 - 428
• Main Authors: Miyazaki, Shigenori, Kamidono, Sadao, Arakawa, Soichi, Kataoka, Nobuo, Hazama, Minoru, Takeda, Masashi, Yamashita, Masuo, Ohbe, Satoshi
• Format: Journal Article
• Language: Japanese
• Published: Japanese Society of Chemotherapy 25.03.1996
• ISSN: 1340-7007; 1884-5886
• DOI: 10.11250/chemotherapy1995.44.Supplement1_420

NM441, a new quinolone derivative, was given to 40 patients with non-catheterized complicated urinary tract infections (UTI) to evaluate clinical efficacy and safety. To 14 patients NM441, at the daily dose of 200 or 400mg, was administered for 5-7 days, and to 26 patients for 14 days. According to the criteria proposed by the Japanese UTI committee, clinical efficacy was evaluated at 5-7 days on 9 patients, and at day 7 and day 14 on 17 patients. After 14-days treatment the rate of recurrence was assessed by bacterial counts in urine. The results were as follows. 1) Overall clinical efficacy rate on 5-7-days treatment group was 100%(9/9). Bacteriologically, 14 of 15 strains (93.3%) were eradicated. 2) Overall clinical efficacy rates on 14-days treatment group were 76.5%(13/17) at day 7 and day 14. Bacteriologically, 21 of 25 strains (84.0%) were eradicated at day 7 and day 14. Final efficacy rates and eradication rates were the same as at day 7 and as at day 14. 3) Eight patients were assessable for recurrence of infections at 1-2 weeks after treatment, relapse was observed on 1 patient. Five patients were assessable for recurrence of infections at 3-6 weeks after treatment, re-infection and relapse was each observed in 1 patient. 4) Side effect was noted in 1 patient with angular stomatitis, but the symptom was mild and transient. No abnormal laboratory findings were observed.