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

NCT00359970 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2015-06-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Azithromycin 500 mg

A single 500 mg dose at the start of treatment

DRUG

Azithromycin 1000 mg

A single 1000 mg dose at the start of treatment

DRUG

Loperamide

A single 4 mg loading dose at the start of treatment and then 2 mg after each loose stool

OTHER

Placebo

A single loading dose at the start of treatment and then a dose after each loose stool

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Charles D. Ericsson, MD · University of Texas Medical School at Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2003-08-31
Completion
2003-08-31

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00359970 on ClinicalTrials.gov