NCT03065374

Treatment for Clostridium-difficile Infection With IMM529

A Phase I/II, Randomized, Double Blind, Placebo-controlled Clinical Study of IMM529 for the Treatment of Clostridium-difficile Infection (CDI).

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Immuron Ltd. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Clostridium Difficile Infection
• Clostridium Difficile Infection Recurrence

Interventions

Type	Name	Description
BIOLOGICAL	IMM-529	IMM-529
OTHER	Placebo	Matching placebo

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-11-07
• Completion: 2019-11-07
• First posted: 2017-02-27
• Last updated: 2019-12-26

Locations

2 sites across 1 country: Israel