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

Primary Purpose

Traveler's Diarrhea

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rifamycin SV-MMX®
Ciprofloxacin
Sponsored by
Dr. Falk Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traveler's Diarrhea

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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,

Sites / Locations

  • Site 401
  • Site 200
  • Site 101
  • Site 124
  • Site 118
  • Site 120
  • Site 104
  • Site 114
  • Site 116
  • Site 107
  • Site 110
  • Site 123
  • Site 122
  • Site 102
  • Site 115
  • Site 119
  • Site 111
  • Site 109
  • Site 103

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Rifamycin SV-MMX® 200 mg tablets

Ciprofloxacin 500 mg capsules

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 23, 2010
Last Updated
October 16, 2018
Sponsor
Dr. Falk Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01208922
Brief Title
Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
Acronym
ERASE
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traveler's Diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
835 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Rifamycin SV-MMX® 200 mg tablets
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Ciprofloxacin 500 mg capsules
Intervention Type
Drug
Intervention Name(s)
Rifamycin SV-MMX®
Intervention Description
2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
Primary Outcome Measure Information:
Title
Time to Last Unformed Stool (TLUS)
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Number of Patients With Clinical Cure
Description
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.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Robert Steffen, M. D.
Organizational Affiliation
University of Zurich, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 401
City
Quito
Country
Ecuador
Facility Name
Site 200
City
Quetzaltenango
Country
Guatemala
Facility Name
Site 101
City
Mapusa
State/Province
Karaswada
Country
India
Facility Name
Site 124
City
Ajmer
Country
India
Facility Name
Site 118
City
Bardez
Country
India
Facility Name
Site 120
City
Calangute
Country
India
Facility Name
Site 104
City
Hyderabad
Country
India
Facility Name
Site 114
City
Kolkata
Country
India
Facility Name
Site 116
City
Lucknow
Country
India
Facility Name
Site 107
City
Margao
Country
India
Facility Name
Site 110
City
Margao
Country
India
Facility Name
Site 123
City
New Delhi
Country
India
Facility Name
Site 122
City
Panaji
Country
India
Facility Name
Site 102
City
Pondichéry
Country
India
Facility Name
Site 115
City
Pushkar
Country
India
Facility Name
Site 119
City
Salcette
Country
India
Facility Name
Site 111
City
Tiswadi
Country
India
Facility Name
Site 109
City
Varanasi
Country
India
Facility Name
Site 103
City
Vijayawada
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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