A Randomized, Double-Blind, Clinical Trial Evaluating Three Single Dose Regimens With Loperamide for Treatment of Ambulatory Watery Travelers' Diarrhea, and Azithromycin With and Without Loperamide for Treatment of Ambulatory Dysentery/Febrile Diarrhea (TrEAT TD)

NCT01618591 NA TERMINATED

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.

Details

Lead sponsor	Uniformed Services University of the Health Sciences
Phase	NA
Status	TERMINATED
Enrolment	384
Start date	2012-09
Completion	2016-03

Conditions

• Acute Watery Diarrhea
• Dysentery/Febrile Diarrhea

Interventions

• Single dose rifaximin 1650 mg
• Single dose azithromycin 500 mg
• Single dose levofloxacin 500 mg
• Single dose azithromycin 1000 mg plus loperamide
• Single dose azithromycin 1000 mg plus placebo

Primary outcomes

• Clinical Cure - Acute Watery Diarrhea group — 24 hours
  * No grade 3-5 stools beyond 24 hours after initiation of therapy meeting diarrhea definition (≥3 loose or liquid stools in 24 hour period). All diarrhea associated symptoms present must be no greater than mild in severity and have no impact on activity. * AND, no treatment failure events to include the following: * Recurrence of diarrheal illness meeting case definition of TD occurring within 72 hours after clinical cure * Worsening of, or failure to improve, clinical symptoms after 24 hours of therapy * Illness continuing after 72 hours
• Clinical Cure - Acute Dysentery/Febrile Diarrhea group — 48 hours
  * No grade 3-5 stools beyond 48 hours after initiation of therapy meeting diarrhea definition (≥3 loose or liquid stools in 24 hour period) and resolution of acute dysentery/febrile diarrhea-associated signs/symptoms to include fever and gross blood in stool, as well as report of no impact on activity * AND, no treatment failure events to include the following: * Recurrence of diarrheal illness meeting case definition of TD occurring within 72 hours after clinical cure * Worsening of, or failure to improve after 24 hours of therapy * Illness continuing after 72 hours

Countries

Afghanistan, Djibouti, Honduras, Kenya, Thailand