A Phase III, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of the Efficacy, Safety, and Tolerability of a Single Infusion of MK-3415 (Human Monoclonal Antibody to Clostridium Difficile Toxin A), MK-6072 (Human Monoclonal Antibody to Clostridium Difficile Toxin B), and MK-3415A (Human Monoclonal Antibodies to Clostridium Difficile Toxin A and Toxin B) in Patients Receiving Antibiotic Therapy for Clostridium Difficile Infection (MODIFY I).

Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of the Efficacy, Safety, and Tolerability of a Single Infusion of MK-3415 (Human Monoclonal Antibody to Clostridium Difficile Toxin A), MK-6072 (Human Monoclonal Antibody to Clostridium Difficile Toxin B), and MK-3415A (Human Monoclonal Antibodies to Clostridium Difficile Toxin A and Toxin B) in Patients Receiving Antibiotic Therapy for Clostridium Difficile Infection (MODIFY I).

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Nov 2017

At a glance

  • Drugs Actoxumab (Primary) ; Actoxumab/bezlotoxumab (Primary) ; Bezlotoxumab (Primary) ; Antibacterials
  • Indications Clostridium infections; Diarrhoea
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms MODIFY-I
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 01 Nov 2017 Results of post-hoc subgroup analysis of MODIFY I and MODIFY II trials assessing C.deficile infection related outcomes, presented at the 25th United European Gastroenterology Week.
    • 08 Oct 2017 Results of exploratory analysis of Modify trials (I and II) assessing genome wide analyses presented at the IDWeek 2017
    • 08 Oct 2017 Results of post-hoc analysis of Modify trials (I and II) assessing outcomes of recurrence clostridium difficle infection in patients with substantial renal impairment presented at the IDWeek 2017
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