Status:
COMPLETED
Azithromycin, With or Without Loperamide, to Treat Travelers' Diarrhea
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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-sul...
Detailed Description
Background. The combination of loperamide and trimethoprim-sulfamethoxazole or a fluoroquinolone has proven to be more efficacious than the antimicrobial agent alone in the treatment of travelers' dia...
Eligibility Criteria
Inclusion
- Eligible subjects included men or women, recently arrived in Mexico, at least 18 years of age, who developed acute diarrhea, which was defined as passage of 3 or more unformed stools in the preceding 24 hours accompanied by one or more signs or symptoms of enteric infection (e.g., nausea, vomiting, abdominal cramps, tenesmus, passage of grossly bloody stools or fecal urgency) with a duration of illness of less than or equal to 72 hours.
Exclusion
- Exclusion criteria included pregnancy, breast feeding, an unstable medical condition, taking two or more doses of an antidiarrheal medication in the 24 hours before enrollment or any number of doses of symptomatic therapy within 2 hours of enrollment, or receiving an antimicrobial drug with expected activity against enteric bacterial pathogens within 7 days prior to enrollment.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT00359970
Start Date
June 1 2002
End Date
August 1 2003
Last Update
June 19 2015
Active Locations (1)
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1
University of Texas Enteric Disease Research Clinics
Guadalajara, Jalisco, Mexico