A randomized, double-blind, multicenter study of rifaximin compared with placebo and with ciprofloxacin in the treatment of travelers' diarrhea.
Rifaximin was compared with placebo and ciprofloxacin for treatment of travelers' diarrhea in a randomized, double-blind clinical trial. Adult travelers (N = 399) consulting travel clinics in Mexico, Guatemala, and India were randomized to receive rifaximin 200 mg three times a day, ciprofloxacin (500 mg two times a day and placebo once a day), or placebo three times a day for 3 days. Patients recorded in daily diaries the time and consistency of each stool and documented symptoms for 5 days after treatment. Stool samples were collected for microbiologic evaluations before and after treatment. The median time to last unformed stool (TLUS) in the rifaximin group (32.0 hours) was less than one half that in the placebo group (65.5 hours; P = 0.001; risk ratio 1.6; 95% confidence interval 1.2, 2.2; primary efficacy endpoint). The median TLUS in the ciprofloxacin group was 28.8 hours (P = 0.0003 versus placebo; P = 0.35 versus rifaximin). Rifaximin was less effective than ciprofloxacin for invasive intestinal bacterial pathogens. Oral rifaximin is a safe and effective treatment of travelers' diarrhea caused by noninvasive pathogens.
Taylor
David N
DN
Salix Pharmaceuticals, Inc., Morrisville, North Carolina, USA. david.taylor@salix.com
Bourgeois
A Louis
AL
Ericsson
Charles D
CD
Steffen
Robert
R
Jiang
Zhi-Dong
ZD
Halpern
Jane
J
Haake
Robert
R
Dupont
Herbert L
HL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000150:complications / Q000188:drug therapy; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003967:Diarrhea / Q000188:drug therapy* / Q000382:microbiology / Q000469:parasitology; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D012294:Rifamycins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000078262:Rifaximin; D014195:Travel; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D005765:Gastrointestinal Agents; D012294:Rifamycins; D002939:Ciprofloxacin; D000078262:Rifaximin