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.

Not Applicable

• Conditions: -A09 Diarrhoea and gastroenteritis of presumed infectious origin; Diarrhoea and gastroenteritis of presumed infectious origin; A09

• Registration Number: PER-056-14
• Lead Sponsor: Dr. Falk de Pharma GmbH,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-17
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Signed informed consent,
2. Men or women between 18 and 85 years of age
3. History of arriving from their country of residence in the industrialized part of the world within the past 4 weeks
4. 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) and able to provide an unformed stool sample during screening (and the latter can be the third unformed stool passed by the patient in the 24 hours prior to randomization). The bacterial origin of diarrhoea will be examined a posteriori” by stool microbiology sampling at the time of screening,
5. Presence of one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesm, fecal urgency),
6. Women of child-bearing potential have to apply during the entire duration of the study a highly effective method of birth control.

Exclusion Criteria

1. Residency in any country with a high incidence rate of traveller’s diarrhoea within the past six months,
2. Fever >100.4°F or 38.0°C
3. Known or suspected infection with non-bacterial pathogen,
4. Presence of diarrhoea of >72 hours duration,
5. Presence of grossly bloody stool,
6. Presence of moderate or severe dehydration
7. History of inflammatory bowel disease (IBD) or celiac disease,
8. Greater than two doses of an anti-diarrhoeal medication within 24 hours before randomisation,
9. Receiving antibacterial drug with expected activity against gram negative bacterial pathogens within 7 days prior to enrolment,
10. History or clinical evidence of severe impairment of liver and renal function,
11. Known intolerance/hypersensitivity/resistance to study drugs,
12. Doubt about the patient’s cooperation, e.g., because of addiction to alcohol or drugs, mental illness, travel schedule,
13. Females, with existing or intended pregnancy or breast-feeding, or not using adequate birth control,
14. Participation in another clinical trial within the last 30 days,
15. Treatment with tizanidine,
16. History of tendon disease / disorder related to quinolone treatment,
17. History or clinical evidence of central nervous disorders which may be disposed to seizures,
18. Risk for torsades de pointes arrhythmia,
19. History or clinical evidence of gastrointestinal obstructions, perforations , or severe intestinal ulcerative lesions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified