Clostridium Difficile Infection Clinical Trial
Official title:
A Phase I/II, Randomized, Double Blind, Placebo-controlled Clinical Study of IMM529 for the Treatment of Clostridium-difficile Infection (CDI).
This study will evaluate the safety and tolerability of IMM-529 together with standard of care (SOC) in patients with Clostridium-difficile Infection.
Subjects who provide voluntary written informed consent will be screened for eligibility.
Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to
participate.
Eligible subjects will be randomized up to 3 weeks post diagnosis of Clostridium-difficile
Infection given SOC initiated already.
Each subject will return to the study clinic for assessment and required study procedures on
Day 7, Day 14, Week 4, Week 8 and Week 12 post randomization. Treatment duration will be 28
days and follow up will last up to 12 weeks post randomization.
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