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