Acute Watery Diarrhea Clinical Trial
Official 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
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.
The study will be a multi-site, randomized, double-blind, controlled clinical trial among
ambulatory deployed personnel. Patients presenting for care will be clinically assessed and
a determination made as to whether they have acute watery diarrhea (AWD) or acute
dysentery/febrile diarrhea (ADF). For the AWD arm, patients will be randomized to receive 1
of 3 regimens: (1) rifaximin 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 (120
subjects); (2) azithromycin 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 (120 subjects); or (3)
levofloxacin 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 (120 subjects).
For the ADF arm, patients will be randomized to receive 1 of 2 regimens: (1) azithromycin
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 (75 subjects); or (2) azithromycin 1000 mg as a
single dose without loperamide (75 subjects).
Study Procedures (Brief): Baseline exam as well as blood and stool samples will be collected
at initial clinic visit. Clinical assessments will be performed at 24 hours, 72 hours, and 7
days. In addition, microbiological cure will be evaluated at 7-d post initiation of
treatment. Subjects will have blood drawn to assess for serological conversion to common
enteric pathogens, and stool collected at 7- and 21-d . Subjects may also opt in for
long-term follow-up at time of enrollment, which will assess for development of
post-infectious functional bowel disorders. All subjects will complete a baseline assessment
at 7-d visit, and those who opt for the additional follow-up will complete a series of
web-based surveys at 3-, 6-, 9-, and 12-m post enrollment.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05216822 -
Anti-Secretory Drug in Treatment of Acute Watery Diarrhea
|
Phase 1 |