Norfloxacin versus co-trimoxazole in the treatment of acute bacterial diarrhoea: A placebo controlled study

Abstract

The bacteriological and clinical efficacy of norfloxacin 400 mg b.i.d. was compared to those of co-trimoxazole (160 mg of trimethoprim plus 800 mg of sulphamethoxazole) b.i.d. and placebo b.i.d. for the treatment of acute bacterial diarrhoea in a randomized double-blind trial. Of a total of 450 patients with acute diarrhoea, 303 had positive bacterial cultures and were evaluable for efficacy. The time to elimination of pathogens was significantly (p < 0.001) shorter in the norfloxacin group than in the co-trimoxazole and placebo group. At completion of treatment, bacteriological cure was found in 97.9%, 72.4% and 38.2% of patients treated with norfloxacin, co-trimoxazole and placebo, respectively. All pathogens were susceptible to norfloxacin and none of them developed resistance to norfloxacine during treatment. In the co-trimoxazole group, resistance to that antibiotic increased from 2% at inclusion to 65.6% at the end of treatment (p < 0.001). In patients with shigellosis or cholera, the mean time to normalization of bowel movements was significantly shorter in the norfloxacin and co-trimoxazole groups than in the placebo group (p < 0.05 and p < 0.01, respectively). There were no significant differences between group with respect to adverse events reported. In conclusion, norfloxacin was well tolerated and highly effective in the treatment of acute bacterial diarrhoea.