Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD)
Condition: Traveler's Diarrhea
MeSH terms: Dysentery; Diarrhea
Intervention: Placebo; Rifamycin SV MMX
Intervention description: Placebo (two matching tablets) orally twice daily for 3 days (72 hours).; Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).
Intervention MeSH terms: Rifamycins; Rifamycin SV
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: traveler's; diarrhea; Rifamycin SV MMX; Rifamycin; MMX; Traveler's Diarrhea

Summary:

      The purpose of this study is to determine whether Rifamycin SV MMX is a safe and effective
      treatment for Traveler's Diarrhea.
    

Eligibility criteria:

        Inclusion Criteria

        Patients were enrolled in the study only if they met all of the following criteria:

          1. Male and female patients 18 years of age or older

          2. Female and male patients of childbearing potential must have agreed to use an
             effective method of birth control (this method must have been approved by the
             investigator and may have included total abstinence from sexual intercourse) during
             the treatment and follow-up study periods; female patients of childbearing potential
             must have had a negative pregnancy test in the 72 hours before randomization; female
             patients who abstained totally from sexual intercourse were not required to take the
             pregnancy test

          3. Recent travel (i.e., must be within 30 days of randomization) from an industrialized
             country

          4. Experiencing signs or symptoms indicative of acute bacterial diarrhea (TD), defined as
             at least three unformed, watery or soft, stools within the 24 hours preceding
             randomization and the duration of illness 72 hours before randomization, and able to
             provide an unformed stool sample during Screening (the latter can be the third
             unformed stool passed by the patient within the 24 hours preceding randomization); the
             bacterial cause of diarrhea was confirmed by microbiology analysis of the stool sample

          5. Experiencing one or more signs or symptoms of enteric infection (moderate to severe
             gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, or
             defecation urgency)

          6. Capable of and willing to give informed consent

        Exclusion Criteria

        Patients were excluded from the study if they met any of the following criteria:

          1. Fever (> 100.4F or 38C) or presence of signs and symptoms of systemic infection Note:
             antipyretic medication should not have been administered in the 6 hours before this
             assessment

          2. Known or suspected infection with non-bacterial pathogen before randomization

          3. Presence of diarrhea for > 72 hours duration

          4. Presence of grossly bloody stool

          5. Presence of moderate to severe dehydration (i.e., presence of orthostatic hypotension
             and/or dehydration requiring treatment with intravenous fluids)

          6. History of ulcerative colitis, diarrhea-predominant irritable bowel syndrome, Crohn's
             disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or
             any other gastrointestinal disease associated with diarrhea. Note: lactose intolerance
             treated with lactase supplements or a lactose-free diet were not excluded if these
             regimens were maintained during the study.

          7. Receiving more than two doses of an antidiarrheal medication (e.g., antimotility,
             absorbent, adsorbent, antisecretory, or probiotics) within 24 hours before
             randomization

          8. Receiving one or more of the following antibiotics, which are active against gram
             negative bacteria TMP-SMX, fluorquinolone, azithromycin or rifaximin within 7 days
             before randomization

          9. Females pregnant or breast feeding or not using adequate birth control

         10. Known intolerance/hypersensitivity/resistance to rifamycin or rifamycin-related
             antibiotics or to any excipient included in the study medications

         11. Patients unable or unwilling to comply with study protocol (e.g., alcoholism, mental
             illness, travel schedule)

         12. Participation in a clinical study with another investigational drug in the 30 days
             prior to randomization or while participating in this study

         13. Previous participation in this study