This study was designed to test the efficacy of 400 mg
fleroxacin given orally as a single dose or once daily for 3 days against acute bacterial
diarrhea. A group of 508 adults with acute
diarrhea were entered into a randomized, double-blind, placebo-controlled, multicenter trial. Patients were examined and asked about numbers of liquid stools daily for 3 days and at 5 days after start of treatment. Repeat stool samples were obtained for culture on days 3 and 5 after start of treatment. A total of 332 patients showed stool cultures positive for bacterial pathogens sensitive to
fleroxacin and completed their treatments. Patients treated with
fleroxacin, both single-dose and 3-day regimens, showed faster clinical improvement than did placebo-treated patients, as shown by earlier cessation of
diarrhea (p < 0.001) and reduction in mean number of loose stools per day on days 2, 3, and 5 after start of
therapy (p < 0.05). Bacteriologic efficacy was demonstrated by negative stool cultures for initial pathogens on days 3 and 5 after start of
therapy in 94% of patients treated with single doses of
fleroxacin and in 93% of patients treated with three doses of
fleroxacin as compared with 57% of patients treated with placebo (p < 0.001). Patients with
cholera,
shigellosis, and
infections due to Vibrio parahaemolyticus showed both clinical and bacteriologic responses to
fleroxacin treatment, whereas patients with
salmonellosis showed only bacteriologic responses. The good overall clinical and bacteriologic responses of most patients with acute bacterial
diarrhea of
fleroxacin indicate that this convenient single-dose
therapy should be advantageous for empiric treatment of certain diarrheal illnesses.