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

Dr. Falk Pharma

Status and phase

Completed

Phase 3

Conditions

Traveler's Diarrhea

Treatments

Drug: Ciprofloxacin

Drug: Rifamycin SV-MMX®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01208922

RIT-1/AID

Details and patient eligibility

About

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.

Enrollment

835 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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,