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 can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Active duty military or military beneficiary, 18 years-old or older.
✓. 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.
✓. Eligible for ambulatory management.
✓. Able to comply with follow-up procedures.
✓. Will remain in country for at least 7 days
Exclusion criteria
✕. Allergy to rifamycins, quinolones, macrolides, or loperamide (not including mild gastrointestinal upset).
✕. Antibiotic therapy in the 72 hours prior to presentation (excluding malaria prophylaxis with mefloquine, malarone, chloroquine/proguanil, or doxycycline).
✕. Concomitant medications with known drug-drug interactions with any of the study drugs (includes theophylline, digoxin, and warfarin).
✕. History of seizures (relative contraindication to quinolones)
What they're measuring
1
Clinical Cure - Acute Watery Diarrhea group
Timeframe: 24 hours
2
Clinical Cure - Acute Dysentery/Febrile Diarrhea group
Timeframe: 48 hours
Trial details
NCT IDNCT01618591
SponsorUniformed Services University of the Health Sciences
✕. Positive pregnancy test at presentation (contraindicated with fluoroquinolone therapy). All female subjects will be administered a urine pregnancy test prior to enrollment.
✕. Presence of symptoms \>96 hours prior to initiating treatment.
✕. Use of \>4 mg loperamide or use of any amount of loperamide for greater than 24 hours prior to enrollment.