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

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

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.

Study Overview

• Status: Completed
• Conditions: Traveler's Diarrhea
• Intervention / Treatment: Drug: Rifamycin SV-MMX®; Drug: Ciprofloxacin

• Study Type: Interventional
• Enrollment (Actual): 835
• Phase: Phase 3

Contacts and Locations

Study Locations

• Ecuador
  • Quito, Ecuador
    • Site 401
• Guatemala
  • Quetzaltenango, Guatemala
    • Site 200
• India
  • Ajmer, India
    • Site 124
  • Bardez, India
    • Site 118
  • Calangute, India
    • Site 120
  • Hyderabad, India
    • Site 104
  • Kolkata, India
    • Site 114
  • Lucknow, India
    • Site 116
  • Margao, India
    • Site 107
  • Margao, India
    • Site 110
  • New Delhi, India
    • Site 123
  • Panaji, India
    • Site 122
  • Pondichéry, India
    • Site 102
  • Pushkar, India
    • Site 115
  • Salcette, India
    • Site 119
  • Tiswadi, India
    • Site 111
  • Varanasi, India
    • Site 109
  • Vijayawada, India
    • Site 103
  • Karaswada
    • Mapusa, Karaswada, India
      • Site 101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Rifamycin SV-MMX® 200 mg tablets	Drug: Rifamycin SV-MMX®; 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
Active Comparator: Group B; Ciprofloxacin 500 mg capsules	Drug: Ciprofloxacin; 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Last Unformed Stool (TLUS)	Time to Last Unformed Stool (TLUS), defined as the interval in hours between the first dose of study drug and the last unformed stool passed, after which clinical cure was declared.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Clinical Cure	Clinical Cure Rate: 24-hour period with no clinical symptoms except mild flatulence, no fever, no watery stools and no more than 2 soft stools OR 48-hour period with no stools or only formed stools, and no fever, with our without symptoms of enteric infection.	5 days

Collaborators and Investigators

• Sponsor: Dr. Falk Pharma GmbH
• Investigators: Principal Investigator: Professor Robert Steffen, M. D., University of Zurich, Switzerland

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 23, 2010
• First Submitted That Met QC Criteria: September 23, 2010
• First Posted (Estimate): September 24, 2010

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Diarrhea; Dysentery; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin; Rifamycins; Rifamycin SV
• Other Study ID Numbers: RIT-1/AID