Drug updated on 10/29/2024
Dosage Form | Tablet (oral; 194 mg) |
Drug Class | Rifamycin antibacterials |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of travelers diarrhea caused by non-invasive strains of Escherichia coli in adults.
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Summary
- This summary is based on the review of one randomized controlled trial(s). [1]
- Rifamycin-SV significantly reduced Time to Last Unformed Stool (TLUS) compared to placebo in all severity groups, with a Hazard Ratio (HR) of 1.9 (P = 0.0006) for all subjects, 5.9 (P = 0.0232) in severe cases, and 1.7 (P = 0.0078) in moderate cases.
- Rifamycin-SV was equally efficacious compared to ciprofloxacin, with HR 0.962 (P = NS) for all subjects, HR 0.9 (P = NS) in moderate cases, and HR 1.2 (P = NS) in severe cases.
- TLUS was longer in severe cases (HR 0.24; P < 0.001; n = 173) compared to moderate (HR 0.54; P = 0.0272; n = 912) and mild cases, but rifamycin-SV showed consistent effectiveness across all severity groups.
- There is no safety information available in the reviewed studies.
- A total of 1098 participants from two double-blind Phase 3 trials were analyzed, categorized into mild, moderate, and severe Traveler's Diarrhea (TD) based on signs, symptoms, and number of loose stools, with the severity classification demonstrating strong prognostic value for holistic assessment and consistent effectiveness of rifamycin-SV across all severity levels.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Aemcolo (rifamycin) Prescribing Information. | 2021 | RedHill Biopharma Inc., Raleigh, NC |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Development of a new travellers' diarrhoea clinical severity classification and its utility in confirming rifamycin-SV efficacy | 1,098Subjects F: 49% M: 51% | 2023 | Journal of Travel Medicine |
Sex Distribution:
F:49%
M:51%
1098Subjects
Year:
2023
Source:Journal of Travel Medicine