Our aim was to compare the efficacy and safety of rifaximin, a virtually nonabsorbed antibiotic, 600 and 1200 mg per day, with placebo in patients with travelers' diarrhea.
This was a multicenter, 1:1:1 randomized, parallel-group, double-blind study, conducted in Antigua, Guatemala; Guadalajara and Morelia, Mexico; and the coast of Kenya north and south of Mombasa. Adult patients with acute travelers' diarrhea were recruited; exclusion criteria included primarily medication that could influence the outcome. Subjects were treated for 3 days, three times daily; follow-up lasted 5 days. For each 24-h period, the subjects completed a diary card. Pre- and posttreatment stool, blood, and urine samples were assessed.
Among the 380 volunteers, median time to the last unformed stool was 32.5 and 32.9 h in both rifaximin groups, compared with 60.0 h with placebo (p
= 0.0001). Also, secondary clinical outcome measures were favorably influenced by the active agent. No relevant side effects were reported.
Rifaximin is efficacious and safe for treatment of travelers' diarrhea at daily doses of 600 mg or higher.