Integrated safety analysis of phase 3 studies for investigational microbiome therapeutic, SER-109, in recurrent CDI

• Main Authors: Matthew Sims (Author), Charles Berenson (Author), Stuart Cohen (Author), Elaine Wang (Author), Elizabeth Hohmann (Author), Richard Nathan (Author), Alberto Odio (Author), Paul Cook (Author), Kelly Brady (Author), David Lombardi (Author), Asli Memisoglu (Author), Ananya De (Author), Brooke Hasson (Author), Bret Lashner (Author), Louis Korman (Author), Doria Grimard (Author), Juan Carlos Moises Gutierrez (Author), Barbara McGovern (Author), Lisa Von Moltke (Author)
• Format: Book
• Published: Cambridge University Press, 2023-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Background: Clostridioides difficile infection (CDI) often recurs in patients aged ≥65 years and those with comorbidities. Clinical trials often exclude patients with history of immunosuppression, malignancy, renal insufficiency, or other comorbidities. In a phase 3 trial (ECOSPOR III), SER-109 was...