Phase 3
Completed N=835
Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
Traveler's Diarrhea
Source: ClinicalTrials.gov NCT01208922 ↗
Enrolled (actual)
835
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Time to Last Unformed Stool (TLUS) — 44.3; 40.3 hours
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Last Unformed Stool (TLUS) |
44.3; 40.3 | — |
| SECONDARY Number of Patients With Clinical Cure |
357; 352 | — |
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,
Data sourced from ClinicalTrials.gov (NCT01208922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.