1306. Randomized, Double-Blind, Placebo-Controlled Study of Rifamycin SV MMX® in the Treatment of Travelers’ Diarrhea
Session: Poster Abstract Session: Below the Diaphragm
Saturday, October 5, 2013
Room: The Moscone Center: Poster Hall C
  • 1306_IDWPOSTER.pdf (493.8 kB)
  • Background: Travelers’ diarrhea (TD) is the most common gastrointestinal illness contracted by persons visiting developing countries. In a study conducted in Guatemala and Mexico, rifamycin SV MMX®(RIF-MMX), a novel broad-spectrum, negligibly-absorbed antibiotic coupled with technology to target drug delivery to the colon, was assessed as oral treatment for TD.

    Methods: A total of 264 adult tourists, presenting within 72 h of TD onset, were randomized (3:1) to receive 3-day treatment with RIF-MMX 400 mg twice daily (N=199) or placebo (PBO; N=65). Patients documented symptoms through Day 5. Stool samples for microbiologic evaluation were collected at baseline and post-treatment.

    Results: In the intent-to-treat population (mean [SD] age 28 [12] years; 50% male; 88% Caucasian), median (95% CI) time from starting drug to last unformed stool before recovery (TLUS; primary endpoint) in the RIF-MMX group was 46.0 (42.8, 50.5) h vs. 68.0 (48.7, not calculable) h in the PBO group (p=0.0008). Fewer patients in the RIF‑MMX group (37; 19%) failed to achieve clinical cure or required rescue medication vs. the PBO group (28; 43%; p<0.001). During the 48-72 h post-treatment time interval, 78 (40%) patients treated with RIF-MMX reported complete resolution of signs and symptoms of TD compared with 12 (19%) patients treated with PBO. The pathogen mix at 4 sites that enrolled 90% (237/264) of patients was similar (positive-detection rate 72%), with diarrheagenic E. coli (141 [60%] patients) being the most common non-invasive pathogen at baseline. For these sites, E.coli eradication was observed post-treatment in 53 (50%) patients in the RIF-MMX group vs. 16 (44%) patients in the PBO group. No statistically significant difference was observed in eradication rates between groups (p=0.532). Treatment-emergent adverse events were more frequent with PBO (38.5%) than with RIF‑MMX (29.6%), consistent with reduced risk of systemic side effects with colonic delivery of a negligibly-absorbed antibiotic.

    Conclusion: The results of this study indicated that RIF-MMX provided effective treatment for TD caused by non‑invasive pathogens, with a positive safety profile.

    Herbert Dupont, MD, FIDSA1, Annkatrin Petersen, MD2, Jose Flores-Figueroa, MD3, Eddy Motta, MD4, Rodolfo Sanchez, MD5, Jeff Zhao, MS6, Arley Mundt, MA6, Mark Totoritis, MD6 and David Ballard, MD6, (1)University of Texas, School of Public Health, Houston, TX, (2)Parimed, Carlsbad, CA, (3)University of Texas at Houston, HSC, Houston, TX, (4)Clínica Santa Catalina, Antigua, Guatemala, (5)Edificio Médico San Lucas, Quetzaltenango, Guatemala, (6)Santarus, Inc., San Diego, CA


    H. Dupont, Santarus Inc: Investigator, Research grant and Research support

    A. Petersen, Santarus, Inc: Consultant, Consulting fee

    J. Flores-Figueroa, None

    E. Motta, Santarus, Inc: Investigator, Research grant and Research support

    R. Sanchez, Santarus, Inc: Investigator, Research grant and Research support

    J. Zhao, Santarus Inc: Employee and Shareholder, Salary

    A. Mundt, Santarus, Inc: Employee and Shareholder, Salary

    M. Totoritis, Santarus, Inc: Employee and Shareholder, Salary

    D. Ballard, Santarus, Inc: Employee and Shareholder, Salary

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