Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
X
Search
Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Mar 2023

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Actoxumab/bezlotoxumab (Primary) ; Bezlotoxumab (Primary) ; Actoxumab; Fidaxomicin; Metronidazole; Metronidazole; Vancomycin
  • Indications Clostridium difficile infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms MODIFY II
  • 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

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top