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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: Ciprofloxacin; Rifamycin SV; Rifamycins

Criteria

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,