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

Traveler's Diarrhea Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208922
• Other study ID #: RIT-1/AID
• Status: Completed
• Phase: Phase 3
• Start date: November 2010
• Est. completion date: May 2016

Study information

• Verified date: October 2018
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 835
• Est. completion date: May 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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,

Related Conditions & MeSH terms

• Diarrhea
• Dysentery
• Traveler's Diarrhea

Intervention

Drug:
• Rifamycin SV-MMX®
2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
• Ciprofloxacin
1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Countries where clinical trial is conducted

Ecuador,  Guatemala,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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