Evidence map›Paper›PMID 38941068›Full record

ArticleInfectious diseases and therapy2024

Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI.

Colleen S Kraft, Matthew Sims, Michael Silverman, Thomas J Louie, Paul Feuerstadt, Edward S Huang, Sahil Khanna, Charles S Berenson, Elaine E L Wang, Stuart H Cohen and 16 more

Erratum issued 2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Infectious diseases and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03183128 phase3completednot on this map

A Phase 3 Multicenter, RandomizeEd, Double Blind, Placebo COntrolled, Parallel Group Study to Evaluate the Safety, Tolerability, & Efficacy of SER-109 vs. Placebo to Reduce Recurrence of ClOstRidium Difficile Infection (CDI) in Adults

TypeinterventionalSponsorSeres Therapeutics, Inc.Ran2017 to 2020Enrolled182ConditionsClostridium Difficile InfectionArmsSER-109, Placebo
NCT03183141 phase3completednot on this map

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)

TypeinterventionalSponsorSeres Therapeutics, Inc.Ran2017 to 2022Enrolled263ConditionsClostridioides Difficile InfectionArmsSER-109
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Colleen S KraftDepartment of Pathology and Laboratory Medicine, Division of Infectious Diseases, Emory University, Atlanta, GA, USA.
Matthew SimsSection of Infectious Diseases and International Medicine, Department of Internal Medicine, Beaumont Royal Oak, Royal Oak, MI, USA.
Michael SilvermanWestern University, London, ON, Canada.
Thomas J LouieCumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Paul FeuerstadtDivision of Digestive Disease, Yale University School of Medicine, New Haven, CT, USA.
Edward S HuangDepartment of Gastroenterology, Palo Alto Medical Foundation, Sutter Health, Mountain View, CA, USA.
Sahil KhannaDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
Charles S BerensonUniversity at Buffalo, VA Western New York Healthcare System, Buffalo, NY, USA.
Elaine E L WangSeres Therapeutics, 200 Sidney Street, Cambridge, MA, 02139, USA.
Stuart H CohenUniversity of California Davis Health, Sacramento, CA, USA.
Louis KormanGastroenterology and Hepatology, Chevy Chase Clinical Research, Chevy Chase, MD, USA.
Christine LeeIsland Medical Program, University of British Columbia and University of Victoria, Vancouver, BC, Canada.
Colleen R KellyDivision of Gastroenterology, Brigham and Women's Hospital, Boston, MA, USA.
Alberto OdioAdventist Health, Simi Valley, CA, USA.
Paul P CookBrody School of Medicine at East, Carolina University, Greenville, NC, USA.
Bret LashnerCleveland Clinic, Cleveland, OH, USA.
Mayur RameshDivision of Infectious Diseases, Henry Ford Health, Detroit, MI, USA.
Princy KumarDivision of Infectious Diseases and Tropical Medicine, Georgetown University Medical Center, Washington, DC, USA.
Ananya DeSeres Therapeutics, 200 Sidney Street, Cambridge, MA, 02139, USA.
Asli MemisogluSeres Therapeutics, 200 Sidney Street, Cambridge, MA, 02139, USA.
David A LombardiSeres Therapeutics, 200 Sidney Street, Cambridge, MA, 02139, USA.
Brooke R HassonSeres Therapeutics, 200 Sidney Street, Cambridge, MA, 02139, USA. bhasson@serestherapeutics.com.ORCID http://orcid.org/0009-0000-2991-0567
Barbara H McGovernSeres Therapeutics, 200 Sidney Street, Cambridge, MA, 02139, USA.
Lisa von MoltkeSeres Therapeutics, 200 Sidney Street, Cambridge, MA, 02139, USA.
Darrell S PardiDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
ECOSPOR III and ECOSPOR IV investigators

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

introductionRecurrent Clostridioides difficile infection (rCDI) often occurs after standard-of-care antibiotics. VOWST oral spores (VOS, previously SER-109), an FDA-approved orally administered microbiome therapeutic, is indicated to prevent rCDI following antibiotics for rCDI. OBJECTIVE, DESIGN, AND PATIENTS: To evaluate safety and efficacy of VOS from two phase 3 trials, (randomized, placebo-controlled [ECOSPOR III: NCT03183128] and open-label, single arm [ECOSPOR IV: NCT03183141]) of 349 adults with rCDI and prevalent comorbidities.

methodsVOS or placebo [ECOSPOR III only] (4 capsules once daily for 3 days). Integrated analysis of treatment-emergent adverse events (TEAEs) collected through week 8; serious TEAEs and TEAEs of special interest collected through week 24; and rates of rCDI (toxin-positive diarrhea requiring treatment) evaluated through weeks 8 and 24.

resultsTEAEs were mostly mild or moderate and gastrointestinal. Most common treatment-related TEAEs were flatulence, abdominal pain and distension, fatigue, and diarrhea. There were 11 deaths (3.2%) and 48 patients (13.8%) with serious TEAEs, none treatment-related. The rCDI rate through week 8 was 9.5% (95% CI 6.6-13.0) and remained low through 24 weeks (15.2%; 95% CI 11.6-19.4). Safety and rCDI rates were consistent across subgroups including age, renal impairment/failure, diabetes, and immunocompromise/immunosuppression.

conclusionsVOS was well tolerated and rates of rCDI remained low through week 24 including in those with comorbidities. These data support the potential benefit of VOS following antibiotics to prevent recurrence in high-risk patients.

trial registrationClinicalTrials.gov identifier, NCT03183128 and NCT03183141.

Indexed as

Clostridioides difficile infectionMicrobiomeMicrobiome therapeuticsRecurrent C. difficile infection

Identifiers

PMID38941068
PMCPMC11416444

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.