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).
Phase of Trial: Phase III
Latest Information Update: 10 Mar 2018
At a glance
- Drugs Actoxumab (Primary) ; Actoxumab/bezlotoxumab (Primary) ; Bezlotoxumab (Primary) ; Antibacterials
- Indications Clostridium-difficile-infections; Diarrhoea
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms MODIFY-I
- Sponsors Merck Sharp & Dohme
- 10 Mar 2018 Results of pooled post-hoc analysis by using data from two studies (MODIFY I and MODIFY II) published in the Clinical Infectious Diseases.
- 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
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History