Overview

Azithromycin, With or Without Loperamide, to Treat Travelers' Diarrhea

Status:
Completed
Trial end date:
2003-08-01
Target enrollment:
Participant gender:
Summary
In a previous study azithromycin proved as efficacious as levofloxacin in the treatment of travelers' diarrhea in Mexico. Because the addition of loperamide to some antibiotics (e.g., trimethoprim-sulfamethoxazole and ofloxacin) has proven more efficacious than antibiotic alone in the treatment of travelers' diarrhea, we decided to study the addition of loperamide to azithromycin. US adults with acute diarrhea in Guadalajara Mexico were randomized to receive azithromycin in two different doses or loperamide plus azithromycin. The duration of diarrhea was shorter (11 hours) in the combination-treated group compared to the antibiotic-treated groups (34 hours). The percentage of subjects continuing to pass 6 or more unformed stools in the first 24 hours was less (1.7%) in the combination-treated group than in the antibiotic-treated groups (20%). We feel loperamide should routinely be added to an antibiotic to optimize treatment of travelers' diarrhea.
Phase:
Phase 4
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston
Treatments:
Antidiarrheals
Azithromycin
Loperamide