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Treatment for Clostridium-difficile Infection With IMM529

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).

Clinical Trial Summary

This study will evaluate the safety and tolerability of IMM-529 together with standard of care (SOC) in patients with Clostridium-difficile Infection.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03065374
Study type Interventional
Source Immuron Ltd.
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date September 1, 2017
Completion date November 7, 2019
View Details
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