A randomized, controlled, single-blind study comparing furazolidone with trimethoprim-sulfamethoxazole in the empirical treatment of acute invasive diarrhea.

An outpatient study of 125 children with acute invasive diarrhea was conducted at the Hospital Infantil de Mexico Federico Gomez. Through a single-blind randomization, we compared the efficacy of furazolidone, 7.5 mg/kg/day (49 patients), with trimethoprim-sulfamethoxazole (TMP-SMX), 8 mg/40 mg/kg/day (52 patients), each given for 5 days. A control group of 24 patients received no antimicrobials. Stool samples were collected from all patients at the time of admission, and active drugs were administered before the stool culture results were available. At baseline, 48 of 125 patients (38.5%) had negative stool cultures. In the other patients, the most frequently isolated pathogens were Shigella sp and enteropathogenic Escherichia coli. Of the total population who completed the study 43 of 49 (87.8%) of the patients in the furazolidone group and 43 of 52 (82.7%) of the patients in the TMP-SMX group achieved clinical cure by day 3, compared with 10 of 22 (45.5%) of the patients in the control group. Day 3 cure rates were similar between groups, independent of baseline stool culture results. Of those patients who had positive stool cultures on day 1, 20 of 34 (58.8%) in the furazolidone group and 19 of 29 (65.5%) in the TMP-SMX group had negative culture results on day 6, compared with 4 of 12 (33.3%) in the control group. Overall, clinical and bacteriologic success was achieved in 31 of 49 (63%) patients treated with furazolidone and in 36 of 52 (69%) patients treated with TMP-SMX, compared with 5 of 22 (23%) patients in the control group.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes