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Acute Watery Diarrhea | Trial Evaluating Ambulatory Treatment of Travelers' Diarrhea

Acute Watery Diarrhea research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. Active duty military or military beneficiary, 18 years-old or older. 2. Presence of acute diarrhea (3 or more stools in 24 hours or 2 or more stools in 24 hours and associated symptoms such as nausea, vomiting, abdominal cramps or tenesmus) and <96 hours duration. 3. Eligible for ambulatory management. 4. Able to comply with follow-up procedures. 5. Will remain in country for at least 7 days Exclusion Criteria: 1. Allergy to rifamycins, quinolones, macrolides, or loperamide (not including mild gastrointestinal upset). 2. Antibiotic therapy in the 72 hours prior to presentation (excluding malaria prophylaxis with mefloquine, malarone, chloroquine/proguanil, or doxycycline). 3. Concomitant medications with known drug-drug interactions with any of the study drugs (includes theophylline, digoxin, and warfarin). 4. History of seizures (relative contraindication to quinolones) 5. Positive pregnancy test at presentation (contraindicated with fluoroquinolone therapy). All female subjects will be administered a urine pregnancy test prior to enrollment. 6. Presence of symptoms >96 hours prior to initiating treatment. 7. Use of >4 mg loperamide or use of any amount of loperamide for greater than 24 hours prior to enrollment.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Watery Diarrhea

Dysentery/Febrile Diarrhea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Single dose rifaximin 1650 mgRifaximin 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 mgAzithromycin 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 mgLevofloxacin 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 loperamideAzithromycin 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 placeboAzithromycin 1000 mg as a single dose and placebo in lieu of loperamide

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Acute Watery Diarrhea

Acute Dysentery/Febrile

Study Status

Terminated

Start Date: September 2012

Completed Date: March 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Clinical Cure - Acute Watery Diarrhea group

Secondary Outcome: Time to Last Unformed Stool

Study sponsors, principal investigator, and references

Principal Investigator: Mark Riddle, MD, DrPH

Lead Sponsor: Uniformed Services University of the Health Sciences

Collaborator: Navy Bureau of Medicine and Surgery

More information:https://clinicaltrials.gov/show/NCT01618591

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