Facilitated By

San Antonio Medical Foundation

Ecospor Iv: An Open-Label Extension Of Study SERES-012 Evaluating SER-109 In Adult Subjects With Recurrent Clostridium Difficile Infection (RCDI)

Brooke Army Medical Center

Brooke Army Medical Center (BAMC) at Fort Sam Houston, Texas, is proud to provide safe, quality care to our military service members, their families, veterans and civilian emergency patients as the most robust and productive healthcare organization within the Military Health System (MHS).

Principal Investigator(s)
Email for information
Funded by
Geneva
Research Start Date
Status
Active

ECOSPOR IV is an open-label extension of Study SERES-012. This study is designed to evaluate the safety, tolerability, and efficacy of a treatment regimen SER-109 in adult subjects 18 years of age or older with recurrent Clostridium difficile infection (RCDI), who received a treatment regimen of SER-109 or placebo in Study SERES012 and had adequate clinical response following the standard of care antibiotic therapy. For this study, CDI recurrence during the study is defined by the following criteria: Positive CDI test on a stool sample determined by a toxin assay, ? 3 unformed bowel movements per day over 2 consecutive days and the requirement that patients must continue to have diarrhea until antibiotic treatment is initiated, and assessment by the investigator (based on clinical assessment) that the patients condition warrants antibiotic treatment.

Collaborative Project
Clinical Care
Infectious Disease
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