Basic and Clinical Studies of Pazufloxacin on Infectious Enteritis Research Group of T-3761 on Infectious Enteritis (Manager; Shoichiro IRIMAJIRI)

Abstract

A clinical study was carried out on pazufloxacin (PZFX) in 137 patients including shigellosis, Salmonella enteritis, enteropathogenic Esherichia coli enteritis and cholera, and carriers of these pathogens. Antibacterial activity of PZFX against clinical isolates, fecal concentration of PZFX and effects of PZFX on fecal microflora were also investigated.
The overall clinical efficacy rate was 97.2%.
The bacteriological efficacy rates were 98.2% against Shigella spp., 81.8% against Salmonella spp., 50% against Vibrio cholerae 01, and 100% against E. coli, V. parahaemolyticus, Aeronomas spp., Plesionomas shigelloides and V. cholerae non-01, respectively.
Side effect (epigastralgia) was observed in 1 of 130 cases (0.8%).The rate of abnormal laboratory findings was 11.2%(11/98). These were mainly elevation of GOT and/or GPT and increased eosinophils.
The clinical usefulness rate was 95.2%.
The MIC₉₀ values of PZFX against Shigella spp., Salmonella spp. and E. coli were 0.025, 0.025 and 0.025, μg/ml, respectively.
The results of fecal drug concentration and the effects on fecal microflora in one patient were compatible with those obtained in healthy volunteers.