Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03183141

ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection

Clostridioides Difficile Infection Clinical Trial

Official title:
ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Subjects With Recurrent Clostridioides Difficile Infection (RCDI)

Clinical Trial Summary

Cohort 1: Subjects who had a Clostridioides difficile infection (CDI) recurrence in study SERES-012 within 8 weeks of receipt of study drug will be eligible. The purpose of this cohort is to assess safety and efficacy of SER-109 in reducing recurrence of CDI in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in study SERES-012. Cohort 2: Cohort 2 is an open-label program for subjects who were not part of SERES-012. The purpose of this cohort is to describe safety and tolerability of SER-109 in subjects 18 years of age or older with at least a first recurrence of CDI.

Clinical Trial Description

Cohort 1 is an open-label extension of study SERES-012. Subjects who had a CDI recurrence in study SERES-012 within 8 weeks of receipt of study drug, have responded to a course of standard of care (SOC) antibiotic treatment, will receive an oral dose of SER-109. A treatment regimen of SER-109 is defined as an oral dose of SER-109 (4 capsules once daily) for 3 consecutive days. Approximately 30 eligible subjects with recurrent CDI disease from study SERES-012 are expected to enroll. Screening for this study will begin at the Recurrence Visit of Study SERES-012. Cohort 2 is an open-label program for subjects who were not part of SERES-012. Subjects 18 years of age or older who had one or more CDI recurrence and have responded to a course of antibiotic treatment will receive an oral dose of SER-109. The CDI recurrence must be confirmed by a positive C. difficile stool toxin or polymerase chain reaction (PCR) assay to confirm eligibility. A treatment regimen of SER-109 is defined as an oral dose of SER-109 (4 capsules once daily) for 3 consecutive days. Approximately 200 eligible subjects with recurrent CDI disease are expected to enroll. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03183141
Study type Interventional
Source Seres Therapeutics, Inc.
Contact
Status Completed
Phase Phase 3
Start date October 23, 2017
Completion date April 29, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03895593 - Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections
Withdrawn NCT04679324 - The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridioides Difficile Infection
Completed NCT04675723 - The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection
Recruiting NCT05693077 - Clostridioides Difficile Colonisation Phase 1
Completed NCT04668014 - The Characteristics and Role of Mucosal Microbiome After Treatment of Clostridioides Difficile Infection
Recruiting NCT05709184 - Lyophilized Fecal Microbiome Transfer vs. Vancomycin Monotherapy for Primary Clostridioides Difficile Infection N/A
Terminated NCT05526807 - Ursodeoxycholic Acid in C. Difficile Infection N/A
Recruiting NCT06306014 - Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients Phase 1/Phase 2
Recruiting NCT06237452 - VE303 for Prevention of Recurrent Clostridioides Difficile Infection Phase 3
Terminated NCT04802837 - Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects Phase 3
Active, not recruiting NCT04885946 - Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection N/A
Recruiting NCT04305769 - Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT) Phase 2
Recruiting NCT06106698 - Washed Microbiota Transplantation for Clostridioides Difficile Infection
Active, not recruiting NCT04781387 - Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection Phase 2
Completed NCT03595553 - Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection Phase 3
Completed NCT03595566 - To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection Phase 3
Completed NCT04725123 - Addressing Personalized Needs in Clostridioides Difficile Infection N/A
Not yet recruiting NCT05852587 - Xylitol Use for Decolonization of C. Difficile in Patients With IBD Phase 1
Completed NCT03788434 - Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection Phase 2
Recruiting NCT05612672 - Evaluation of GeoHAI Implementation N/A