To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

  • STATUS
    Recruiting
  • participants needed
    680
  • sponsor
    Summit Therapeutics
Updated on 27 October 2021
Investigator
Martin Oyanguren
Primary Contact
Hospital Nacional Edgardo Rebagliati Martins (2.5 mi away) Contact
+181 other location
antibiotic therapy
antibiotics
diarrhea
vancomycin
clostridium difficile
ridinilazole

Summary

Summit is developing ridinilazole as a novel antimicrobial for Clostridium difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of achieving comparable cure rates to standard of care, but reducing rates of recurrent disease.

A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted.

The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin.

Details
Condition Clostridium Difficile Infection, Clostridioides Difficile Infection
Treatment Vancomycin, ridinilazole
Clinical Study IdentifierNCT03595566
SponsorSummit Therapeutics
Last Modified on27 October 2021

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