Abstract
Microbiological and clinical studies of temafloxacin (TMFX), a novel new quinolone antimicrobial agent, were carried out.
1) Microbiological Study: The MICs of TMFX against 550 strains of 12 species of clinical isolates preserved at our department were determined with the MIC2000 system, and compared with the antimicrobial activities of ofloxacin (OFLX) and ciprofloxacin (CPFX). The MIC90's of TMFX against such gram-positive cocci as methicillin-sensitive Staphylococcus aureus, methicillinresistant S. aureus, Staphylococcus epidermidis, Enterococcus faecalis and Enterococcus faecium were all below 12.5 μ g/ml. TMFX exhibited more powerful activity against these organisms than did the comparative drugs. On the other hand, the MIC90's of TMFX against gram-negative rods were below 3.13μ g/ml except for Pseudomonas aeruginosa and Serratia marcescens against which its MIC90's were 100μg/ml and 12.5μg/ml, respectively. When compared with the other drugs tested in terms of MIC90's, TMFX was slightly less active against Escherichia coli, Enterobater species, and P. aeruginosa than CPFX, but showed about the same activity as did OFLX. TMFX was slightly less active against Klebsiella pneumoniae, Indole (+) Proteus species, and S. marcescens than CPFX, but showed more powerful activity than did OFLX. Furthermore, TMFX showed a somewhat higher MIC90 value against Proteus mirabilis than did either of the comparative drugs.
2) Clinical Study: TMFX was administered to 3 patients with acute uncomplicated cystitis and 18 patients with complicated urinary tract infection, 21 patients in all. All three cases of acute uncomplicated cystitis were evaluable according to the criteria of the Japanese UTI Committee, and the efficacy rate was 100%, as determined at day 3 of treatment. In these cases, all three strains were eliminated after treatment. Among 18 cases of complicated urinary tract infection, 12 were evaluable according to the criteria of the Japanese UTI Committee. At day 5 of treatment, the response was excellent in 4 cases, good in 4 cases, and poor in 4 cases, the efficacy rate being 66.7%. The nonresponders included 2 patients with an indwelling catheter and one with an infection with several species of organisms including Pseudomonas species.
No adverse drug reactions were observed in any of the 21 patients in our series.
