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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)

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Trial Profile

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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Mar 2023

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At a glance

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

Most Recent Events

  • 09 Mar 2023 Results of pooled analysis of pharmacokinetic modeling study assessed whether hematopoietic stem cell transplant recipients, at increased risk of CDI and exhibiting decreased albumin levels within the first month posttransplant, are at risk of clinically relevant reductions in bezlotoxumab exposure from NCT01241552/NCT01513239, PN004, PN005, and PN006, NCT01777763 and NCT01691248 studies, published in the Clinical Therapeutics.
  • 31 Jul 2020 Results (n=2655) of post-hoc analysis of pooled MODIFY I/II data published in the Clinical Infectious Diseases
  • 06 Jun 2020 Results of post hoc analysis in subgroup of patients from studies (Modify I and Modify II) published in the European Journal of Clinical Microbiology and Infectious Diseases

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