Trial Evaluating Ambulatory Treatment of Travelers' Diarrhea

• Register: ClinicalTrials.gov
• Last refreshed on: 5 December 2016
• Main ID: NCT01618591
• Date of registration: 01/06/2012
• Prospective Registration: Yes
• Primary sponsor: Uniformed Services University of the Health Sciences
• Public title: Trial Evaluating Ambulatory Treatment of Travelers' Diarrhea TrEAT TD
• Scientific title: 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
• Date of first enrolment: September 2012
• Target sample size: 384
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01618591
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Afghanistan, Djibouti, Honduras, Kenya, Thailand

Contacts

• Name: Mark Riddle, MD, DrPH
• Affiliation: Naval Medical Research Center

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Watery Diarrhea

Dysentery/Febrile Diarrhea

Intervention(s)

Drug: Single dose levofloxacin 500 mg

Drug: Single dose rifaximin 1650 mg

Drug: Single dose azithromycin 1000 mg plus placebo

Drug: Single dose azithromycin 1000 mg plus loperamide

Drug: Single dose azithromycin 500 mg

Primary Outcome(s)

Clinical Cure - Acute Watery Diarrhea group [Time Frame: 24 hours]

Clinical Cure - Acute Dysentery/Febrile Diarrhea group [Time Frame: 48 hours]

Secondary Outcome(s)

Time to Last Unformed Stool [Time Frame: 24, 48, 72 hours]

Secondary ID(s)

IDCRP-065

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Naval Medical Research Center

Naval Medical Research Unit- 3

Navy Bureau of Medicine and Surgery

United States Army Medical Unit - Kenya

United States Naval Medical Center, Portsmouth

Ministry of Defence, United Kingdom

Naval Medical Research Unit- 6