Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Fluoroquinolones; Prulifloxacin

Criteria

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