Azithromycin, With or Without Loperamide, to Treat Travelers' Diarrhea
Loperamide Plus Azithromycin More Effectively Treats Travelers' Diarrhea In Mexico Than Azithromycin Alone
1 other identifier
interventional
176
1 country
1
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-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2002
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 1, 2006
CompletedFirst Posted
Study publicly available on registry
August 3, 2006
CompletedJune 19, 2015
June 1, 2015
1.2 years
August 1, 2006
June 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hours from beginning treatment to passage of last unformed stool
subjects recorded the time and form of all stools passed during a 4 day observation period
Secondary Outcomes (5)
Number of unformed stools passed per 24 hour period
24 hours after treatment
Number of subjects with symptoms of enteric disease per 24 hour period
24 hours after treatment
Number of treatment failures
72 hours after treatment
Percent of subjects in whom enteropathogen isolated from an enrollment stool sample was eradicated from a day 5 stool
5 days after treatment
Percent of subjects continuing to pass 3 or more (enrollment criteria) unformed stools in a 24 hour period
24 hours after treatment
Study Arms (3)
Azithromycin 500 mg plus Placebo
ACTIVE COMPARATORa single 500 mg dose of Azitrhomycin at the start of treatment; a single loading dose of placebo at the start of treatment and then a dose of placebo after each loose stool
Azithromycin 1000 mg plus Placebo
ACTIVE COMPARATORa single 1000 mg dose of Azitrhomycin at the start of treatment; a single loading dose of placebo at the start of treatment and then a dose of placebo after each loose stool
Azithromycin 500 mg plus Loperamide
EXPERIMENTALa single 500 mg dose of Azitrhomycin at the start of treatment; a single 4 mg loading dose of Loperamide at the start of treatment and then 2 mg Loperamide after each loose stool
Interventions
A single 500 mg dose at the start of treatment
A single 1000 mg dose at the start of treatment
A single 4 mg loading dose at the start of treatment and then 2 mg after each loose stool
A single loading dose at the start of treatment and then a dose after each loose stool
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Enteric Disease Research Clinics
Guadalajara, Jalisco, Mexico
Related Publications (2)
Adachi JA, Ericsson CD, Jiang ZD, DuPont MW, Martinez-Sandoval F, Knirsch C, DuPont HL. Azithromycin found to be comparable to levofloxacin for the treatment of US travelers with acute diarrhea acquired in Mexico. Clin Infect Dis. 2003 Nov 1;37(9):1165-71. doi: 10.1086/378746. Epub 2003 Sep 30.
PMID: 14557959BACKGROUNDEricsson CD, DuPont HL, Okhuysen PC, Jiang ZD, DuPont MW. Loperamide plus azithromycin more effectively treats travelers' diarrhea in Mexico than azithromycin alone. J Travel Med. 2007 Sep-Oct;14(5):312-9. doi: 10.1111/j.1708-8305.2007.00144.x.
PMID: 17883462BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles D. Ericsson, MD
University of Texas Medical School at Houston
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Dr. and Mrs. Carl V. Vartian Professor in Infectious Diseases
Study Record Dates
First Submitted
August 1, 2006
First Posted
August 3, 2006
Study Start
June 1, 2002
Primary Completion
August 1, 2003
Study Completion
August 1, 2003
Last Updated
June 19, 2015
Record last verified: 2015-06