Acute Gastroenteritis in Adult Travelers
Conditions
Keywords
Gastroenteritis
Brief summary
The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of subjects with acute bacterial gastroenteritis.
Detailed description
This double-blind trial will compare the safety and efficacy of prulifloxacin versus placebo in adult travelers with acute gastroenteritis characterized by diarrhea with one or more of the following signs or symptoms: nausea, vomiting, abdominal pain or cramping, fecal urgency, moderate to severe gas-related symptoms, or tenesmus of ≤72 hours duration.
Interventions
DRUGPrulifloxacin
Tablet
DRUGPlacebo
Tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Acute Bacterial Gastroenteritis; * Traveler from Industrialized Country; * Capable of giving Informed Consent
Exclusion criteria
* Fever (\>100.3 degrees); * Pregnant or Breast Feeding or Not using adequate birth control; * Known or Suspected (co-)Infection with non-bacterial pathogen; * Symptoms of Gastroenteritis of \>72 hours; * Bloody Diarrhea; * Concomitant antibacterial with activity against enteric bacterial pathogens; * History of IBD; * Unable/Unwilling to comply with study protocol; * \> 2 doses of anti-diarrheal medication within 24 hours; * Antimicrobial Treatment within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to last unformed stool | Study days 1-3 |
Secondary
| Measure | Time frame |
|---|---|
| Clinical cure based on relief of signs and symptoms | Study days 1-3 |
| Microbiologic eradication rates | Study days 1-3 |
Countries
United States
Outcome results
None listed