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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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,