Clinical trial NCT01208922: Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Traveler's Diarrhea
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2010-09-24
Enrollment: 835
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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,

Primary outcomes:
measure: Time to Last Unformed Stool (TLUS)
timeFrame: 5 days
Secondary outcomes:
measure: Number of Patients With Clinical Cure
timeFrame: 5 days
Other outcomes:
Locations:
city: Quito
country: Ecuador
facility: Site 401
city: Quetzaltenango
country: Guatemala
facility: Site 200
city: Mapusa
country: India
facility: Site 101
state: Karaswada
city: Ajmer
country: India
facility: Site 124
city: Bardez
country: India
facility: Site 118
city: Calangute
country: India
facility: Site 120
city: Hyderabad
country: India
facility: Site 104
city: Kolkata
country: India
facility: Site 114
city: Lucknow
country: India
facility: Site 116
city: Margao
country: India
facility: Site 107
city: Margao
country: India
facility: Site 110
city: New Delhi
country: India
facility: Site 123
city: Panaji
country: India
facility: Site 122
city: Pondichéry
country: India
facility: Site 102
city: Pushkar
country: India
facility: Site 115
city: Salcette
country: India
facility: Site 119
city: Tiswadi
country: India
facility: Site 111
city: Varanasi
country: India
facility: Site 109
city: Vijayawada
country: India
facility: Site 103
Study officials:
affiliation: University of Zurich, Switzerland
name: Professor Robert Steffen, M. D.
role: PRINCIPAL_INVESTIGATOR
References: