Trial Evaluating Ambulatory Treatment of Travelers' Diarrhea

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uniformed Services University of the Health Sciences
• Collaborators: Ministry of Defence, United Kingdom; Naval Medical Research Center; Naval Medical Research Unit- 3; Naval Medical Research Unit- 6; Navy Bureau of Medicine and Surgery; United States Army Medical Unit - Kenya; United States Naval Medical Center, Portsmouth
• Treatments: Antidiarrheals; Azithromycin; Levofloxacin; Loperamide; Ofloxacin; Rifaximin

Criteria

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.