Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea

A Randomised, Double-blind, Double-dummy, Multi-centre, Comparative Parallel-group Study to Evaluate the Efficacy and Safety of Oral Daily Rifamycin SV-MMX® 400 mg b.i.d. vs. Ciprofloxacin 500 mg b.i.d. in the Treatment of Acute Infectious Diarrhoea in Travellers

The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.

Inclusion Criteria:

• Signed informed consent,
• Men or women between 18 and 85 years of age,
• History of arriving from their country of residence in the industrialized part of the world within the past 4 weeks,
• Presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or soft stools accompanied by symptoms within 24 hours preceding randomisation with duration of illness ≤ 72 hours),
• Presence of one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, fecal urgency),
• Women of childbearing potential had to apply during the entire duration of the study a highly effective method of birth control

Exclusion Criteria:

• Residency in any country with high incidence rate of TD within the past 6 months,
• Fever (defined as a body (oral) temperature >100.4°F or 38.0°C; antipyretic medication should not have been administered in the 6 hours prior to this assessment),
• Known or suspected infection with non-bacterial pathogen,
• Presence of diarrhoea of >72 hours duration,
• Presence of grossly bloody stool,
• Presence of moderate or severe dehydration (i.e. symptoms of hypovolemia such as orthostatic hypotension, dizziness or wrinkling of skin),
• History of inflammatory bowel disease or celiac disease,