Clinical trial NCT02830542: SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence
Official title: A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy of SER-262 in Adults With Primary Clostridium Difficile Infection (CDI) to Prevent Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clostridium Difficile Infection
Keywords: Clostridium difficile
C Diff
CDI
Lead sponsor: Seres Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pharm-Olam International
First posted: 2016-07-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).

Detailed description: SER-262-001 is a Phase 1b, randomized, double blind, placebo-controlled, ascending single dose clinical study with 2 treatment arms (SER-262 or placebo) in up to 8 dose cohorts. Patients who have been diagnosed with their first (primary) episode of CDI, defined as diarrhea (≥ 3 unformed stools per day for 2 consecutive days), a positive C. difficile stool test and who have responded to standard-of-care antibiotic will receive investigational drug or placebo on Day 1.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study.
2. Male or female subjects ≥ 18 years.
3. A primary (first) episode of CDI with documentation of the episode including CDI date, test results, antibiotic treatment (including start and stop dates), and response to treatment

Exclusion Criteria:

1. Females who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
2. Known or suspected toxic megacolon and/or known small bowel ileus.
3. Active irritable bowel syndrome with diarrhea within the previous 12 months.
4. Major gastrointestinal surgery (eg, significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy) or any history of total colectomy or bariatric surgery.
5. History of inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 12 months.
6. Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2
7. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Patients discharged from an intensive care unit before Day 1 may be enrolled.
8. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).
9. Absolute neutrophil count \< 500 cells/mm3

Primary outcomes:
measure: Safety and tolerability of SER-262 as assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings
timeFrame: Up to 24 weeks after treatment
measure: Relative risk of recurrence based on the proportion of subjects experiencing CDI recurrence in each SER-262 cohort compared to placebo up to 8 weeks after treatment
timeFrame: Up to 8 weeks after treatment
Secondary outcomes:
measure: Time to recurrence of CDI
timeFrame: Up to 24 weeks after treatment
measure: Relative risk of recurrence of CDI up to 4, 12, and 24 weeks after treatment
timeFrame: Up to 4, 12, and 24 weeks after treatment
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center, LLC
state: Alabama
city: Fountain Valley
country: United States
facility: Lalla-Reddy Medical Corporation
state: California
city: La Mesa
country: United States
facility: eStudySite
state: California
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Idaho Falls
country: United States
facility: Snake River Research
state: Idaho
city: Annapolis
country: United States
facility: Anne Arundel Health System Research Institute
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Butte
country: United States
facility: Mercury St. Medical Group
state: Montana
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Columbus
country: United States
facility: Remington Davis
state: Ohio
city: Lima
country: United States
facility: Regional Infectious Diseases & Infusion Center
state: Ohio
city: Temple
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Bountiful
country: United States
facility: Dr. Hansen Internal Medicine
state: Utah
city: Lynchburg
country: United States
facility: Infectious Disease Associates of Central Virginia
state: Virginia
Study officials:
affiliation: Seres Therapeutics
name: Michele Trucksis, PhD, MD
role: STUDY_DIRECTOR
References: