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: 16 May 2018

At a glance

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

    • 16 May 2018 Results of a post-hoc analysis of MODIFY I and MODIFY II (n=1554) assessing the efficacy of bezlotoxumab based on timing of administration relative to start of antibacterial therapy, published in the Journal of Antimicrobial Chemotherapy
    • 24 Apr 2018 Results of subgroup analysis assessing effects of bezlotoxumab in patients with solid tumour by using data from MODIFY I and II studies presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases.
    • 24 Apr 2018 Results of post-hoc subgroup analysis assessing effects of bezlotoxumab on patients with haematologic malignancy by using data from MODIFY I and II studies presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases.
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