Trial Evaluating Ambulatory Treatment of Travelers' Diarrhea

Summary

The purpose of the trial is to develop the evidence on relative efficacy of 3 available single-dose loperamide adjuncted regimens for watery diarrhea and a single-dose regimen, with and without loperamide, for dysentery/febrile diarrhea required for informing decisions among these regimens. Information from this study will be used to develop management guidelines for the diagnosis and management of travelers' diarrhea (TD) among deployed United States and United Kingdom military personnel.

Conditions

• Acute Watery Diarrhea
• Dysentery/Febrile Diarrhea

Interventions

DRUG

Single dose rifaximin 1650 mg

Rifaximin 1650 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days

DRUG

Single dose azithromycin 500 mg

Azithromycin 500 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days

DRUG

Single dose levofloxacin 500 mg

Levofloxacin 500 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days

DRUG

Single dose azithromycin 1000 mg plus loperamide

Azithromycin 1000 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days

DRUG

Single dose azithromycin 1000 mg plus placebo

Azithromycin 1000 mg as a single dose and placebo in lieu of loperamide

Sponsors & Collaborators

• Navy Bureau of Medicine and Surgery

  collaborator FED

• Ministry of Defence, United Kingdom

  collaborator OTHER_GOV

• Naval Medical Research Center

  collaborator FED

• Naval Medical Research Unit- 3

  collaborator FED

• United States Army Medical Unit - Kenya

  collaborator FED

• United States Naval Medical Center, Portsmouth

  collaborator FED

• Naval Medical Research Unit- 6

  collaborator FED

• Uniformed Services University of the Health Sciences

  lead FED

Principal Investigators

• Mark Riddle, MD, DrPH · Naval Medical Research Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2016-03-31

Completion

2016-03-31

Countries

• Afghanistan
• Djibouti
• Honduras
• Kenya
• Thailand

Study Locations