Treatment for Clostridium-difficile Infection With IMM529
NCT03065374 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2019-12-26
Summary
This study will evaluate the safety and tolerability of IMM-529 together with standard of care (SOC) in patients with Clostridium-difficile Infection.
Conditions
- Clostridium Difficile Infection
- Clostridium Difficile Infection Recurrence
Interventions
- BIOLOGICAL
-
IMM-529
IMM-529
- OTHER
-
Placebo
Matching placebo
Sponsors & Collaborators
-
Immuron Ltd.
lead INDUSTRY
Principal Investigators
-
Neta Tobis · Immuron Limited
-
Jerry Kanellos · Immuron Limited
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-09-01
- Primary Completion
- 2019-11-07
- Completion
- 2019-11-07
Countries
- Israel
Study Locations
More Related Trials
-
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
NCT03110133 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis
NCT01959048 ·Status: TERMINATED ·Phase: NA
-
Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
NCT04626947 ·Status: TERMINATED ·Phase: PHASE4
-
Freeze-dried, Capsulized FMT for RCDI
NCT02399618 ·Status: UNKNOWN ·Phase: PHASE1
-
SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence
NCT02830542 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Trial of a Single Dose of CRS3123
NCT01551004 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity Study of GSK's Clostridium Difficile Vaccine 2904545A When Administered in Healthy Adults Aged 18-45 Years and 50-70 Years
NCT04026009 ·Status: COMPLETED ·Phase: PHASE1
-
Transplantation of Fecal Microbiota for Clostridium Difficile Infection
NCT01958463 ·Status: UNKNOWN ·Phase: PHASE3
-
A Prospective Trial of Frozen-and-Thawed Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection
NCT02394275 ·Status: TERMINATED ·Phase: PHASE2
-
The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridioides Difficile Infection
NCT04679324 ·Status: WITHDRAWN
-
Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)
NCT03548051 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)
NCT03005379 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection
NCT03806803 ·Status: COMPLETED ·Phase: PHASE2
-
C.Difficile Observational Study
NCT06277999 ·Status: COMPLETED
-
Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection
NCT03973697 ·Status: TERMINATED ·Phase: PHASE2
-
Treatment of Recurrent Clostridium Difficile Infection With RBX7455
NCT02981316 ·Status: COMPLETED ·Phase: PHASE1
-
FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI
NCT02255305 ·Status: TERMINATED ·Phase: PHASE2
-
Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
NCT01887912 ·Status: TERMINATED ·Phase: PHASE3
-
Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea
NCT02801656 ·Status: WITHDRAWN ·Phase: PHASE3
-
Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease
NCT00350298 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Clinical Effectiveness of Oral Probiotic MIYA-BM to Prevent Recurrent Clostridium Difficile Infections
NCT01077245 ·Status: WITHDRAWN ·Phase: PHASE2
-
Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridioides Difficile Infection
NCT03834038 ·Status: COMPLETED ·Phase: NA
-
Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study
NCT03918629 ·Status: COMPLETED ·Phase: PHASE3
-
Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease
NCT06799039 ·Status: NOT_YET_RECRUITING ·Phase: EARLY_PHASE1
-
Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
NCT03562741 ·Status: RECRUITING ·Phase: NA