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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
9
Hadassah Medical Center
Jerusalem, Israel
Sheba Hospital
Tel Litwinsky, Israel
Adverse events incidence
Number of adverse events
Time frame: 12 weeks
Adverse events severity
Severity of adverse events
Time frame: 12 weeks
Mortality rate
Mortality rate
Time frame: 0, 7, 14 days and 4, 8, 12 weeks
Disease symptoms incidence
Time to resolution of symptoms defined by cessation of unformed stools
Time frame: 0, 7, 14 days and 4, 8, 12 weeks
Disease symptoms severity
Number of unformed stools per day
Time frame: 0, 7, 14 days and 4, 8, 12 weeks
Recurrence rate
Rate of subjects with recurring symptoms and positive stool test for C-Diff
Time frame: 12 weeks
Recovery rate
Stool sampling - neutralizing antibodies and spores and IMM-529 recovery rate
Time frame: 4, 12 weeks
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