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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03183141
Recruitment Status : Completed
First Posted : June 9, 2017
Results First Posted : March 31, 2023
Last Update Posted : April 10, 2023
Sponsor:
Information provided by (Responsible Party):
Seres Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Clostridioides Difficile Infection
Intervention Biological: SER-109
Enrollment 263
Recruitment Details Overall, there were 64 sites in the United States and 8 sites in Canada that enrolled participants between 2017 to 2021.
Pre-assignment Details  
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description Rollover participants from study SERES-012, who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in SERES-013 study. Newly enrolled participants who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days.
Period Title: Overall Study
Started 29 234
Completed 8-week Follow-up 29 228
Completed [1] 27 222
Not Completed 2 12
Reason Not Completed
Withdrawal by Subject             2             4
Death             0             8
[1]
Completed 24-week Follow-up
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description Rollover participants from study SERES-012, who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in SERES-013 study. Newly enrolled participants who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. Total of all reporting groups
Overall Number of Baseline Participants 29 234 263
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 234 participants 263 participants
71.7  (12.46) 63.1  (15.79) 64.0  (15.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 234 participants 263 participants
Female
18
  62.1%
162
  69.2%
180
  68.4%
Male
11
  37.9%
72
  30.8%
83
  31.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 29 participants 234 participants 263 participants
White
29
 100.0%
214
  91.5%
243
  92.4%
Black or African American
0
   0.0%
14
   6.0%
14
   5.3%
Asian
0
   0.0%
5
   2.1%
5
   1.9%
American Indian or Alaska Native
0
   0.0%
1
   0.4%
1
   0.4%
Not Hispanic or Latino
29
 100.0%
214
  91.5%
243
  92.4%
Hispanic or Latino
0
   0.0%
20
   8.5%
20
   7.6%
Antibiotic regimen for qualifying episode  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 234 participants 263 participants
Vancomycin
22
  75.9%
169
  72.2%
191
  72.6%
Fidaxomicin
7
  24.1%
65
  27.8%
72
  27.4%
1.Primary Outcome
Title Cohort 1: Recurrence of CDI and Sustained Clinical Response
Hide Description Cohort 1: Recurrence of CDI up to 8 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 Weeks after treatment.
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all enrolled participants.
Arm/Group Title Cohort 1
Hide Arm/Group Description:
Rollover participants from study SERES-012, who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in SERES-013 study.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
Number of participants with CDI recurrence
4
  13.8%
Number of participants with sustained response
25
  86.2%
2.Primary Outcome
Title Cohort 2: Recurrence of CDI and Sustained Clinical Response
Hide Description Cohort 2: Recurrence of CDI up to 8 and 12 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 and 12 Weeks after treatment.
Time Frame Up to Weeks 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all enrolled participants.
Arm/Group Title Cohort 2
Hide Arm/Group Description:
Newly enrolled participants who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days.
Overall Number of Participants Analyzed 234
Measure Type: Count of Participants
Unit of Measure: Participants
Week 8 Number of participants with CDI recurrence
19
   8.1%
Number of participants with sustained clinical response
215
  91.9%
Week 12 Number of participants with CDI recurrence
23
   9.8%
Number of participants with sustained clinical response
211
  90.2%
Time Frame 24 weeks follow-up starting Day 1 post-dosing with SER-109
Adverse Event Reporting Description All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 onwards to the end of study (Week 24), only serious adverse events and adverse events of special interest (e.g., invasive infections) were collected.
 
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description Rollover participants from study SERES-012, who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in SERES-013 study. Newly enrolled participants who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days.
All-Cause Mortality
Cohort 1 Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   8/234 (3.42%) 
Hide Serious Adverse Events
Cohort 1 Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   1/29 (3.45%)   32/234 (13.68%) 
Blood and lymphatic system disorders     
Anemia †  0/29 (0.00%)  1/234 (0.43%) 
Cardiac disorders     
Cardiac failure acute †  0/29 (0.00%)  2/234 (0.85%) 
Acute myocardial infarction †  0/29 (0.00%)  1/234 (0.43%) 
Atrial fibrillation †  0/29 (0.00%)  1/234 (0.43%) 
Cardiac failure chronic †  0/29 (0.00%)  1/234 (0.43%) 
Cardiac failure congestive †  0/29 (0.00%)  1/234 (0.43%) 
Congestive cardiomyopathy †  0/29 (0.00%)  1/234 (0.43%) 
Coronary artery disease †  0/29 (0.00%)  1/234 (0.43%) 
Gastrointestinal disorders     
Clostridium difficile colitis †  0/29 (0.00%)  2/234 (0.85%) 
Diarrhea †  0/29 (0.00%)  2/234 (0.85%) 
Ascites †  0/29 (0.00%)  1/234 (0.43%) 
Duodenal ulcer hemorrhage †  0/29 (0.00%)  1/234 (0.43%) 
Gastric ulcer hemorrhage †  0/29 (0.00%)  1/234 (0.43%) 
Gastric volvulus †  0/29 (0.00%)  1/234 (0.43%) 
Gastrointestinal hemorrhage †  0/29 (0.00%)  1/234 (0.43%) 
Gastrointestinal perforation †  0/29 (0.00%)  1/234 (0.43%) 
Intestinal perforation †  0/29 (0.00%)  1/234 (0.43%) 
Mallory-Weiss syndrome †  0/29 (0.00%)  1/234 (0.43%) 
Small intestinal obstruction †  0/29 (0.00%)  1/234 (0.43%) 
General disorders     
Death due to natural causes †  0/29 (0.00%)  1/234 (0.43%) 
Hepatobiliary disorders     
Bile duct obstruction †  0/29 (0.00%)  1/234 (0.43%) 
Cholangitis †  0/29 (0.00%)  1/234 (0.43%) 
Infections and infestations     
Cellulitis †  0/29 (0.00%)  4/234 (1.71%) 
Urinary tract infection †  0/29 (0.00%)  3/234 (1.28%) 
Clostridium difficile infection †  0/29 (0.00%)  4/234 (1.71%) 
Corona virus infection †  0/29 (0.00%)  2/234 (0.85%) 
Urosepsis †  1/29 (3.45%)  1/234 (0.43%) 
Abscess †  0/29 (0.00%)  1/234 (0.43%) 
Abscess limb †  0/29 (0.00%)  1/234 (0.43%) 
Cytomegalovirus viremia †  0/29 (0.00%)  1/234 (0.43%) 
Endocarditis bacterial †  0/29 (0.00%)  1/234 (0.43%) 
Escherichia bacteremia †  0/29 (0.00%)  1/234 (0.43%) 
Necrotizing fasciitis †  0/29 (0.00%)  1/234 (0.43%) 
Peritonitis †  0/29 (0.00%)  1/234 (0.43%) 
Pneumonia †  0/29 (0.00%)  1/234 (0.43%) 
Injury, poisoning and procedural complications     
Hip fracture †  0/29 (0.00%)  1/234 (0.43%) 
Road traffic accident †  0/29 (0.00%)  1/234 (0.43%) 
Investigations     
Amylase increased †  0/29 (0.00%)  1/234 (0.43%) 
Lipase increased †  0/29 (0.00%)  1/234 (0.43%) 
Platelet count decreased †  0/29 (0.00%)  1/234 (0.43%) 
Metabolism and nutrition disorders     
Dehydration †  0/29 (0.00%)  1/234 (0.43%) 
Musculoskeletal and connective tissue disorders     
Chest wall hematoma †  0/29 (0.00%)  1/234 (0.43%) 
Chronic recurrent multifocal osteomyelitis †  0/29 (0.00%)  1/234 (0.43%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pancreatic carcinoma †  0/29 (0.00%)  1/234 (0.43%) 
Nervous system disorders     
Syncope †  0/29 (0.00%)  2/234 (0.85%) 
Facial paralysis †  0/29 (0.00%)  1/234 (0.43%) 
Transient ischemic attack †  0/29 (0.00%)  1/234 (0.43%) 
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy †  0/29 (0.00%)  1/234 (0.43%) 
Product Issues     
Device occlusion †  0/29 (0.00%)  1/234 (0.43%) 
Renal and urinary disorders     
Acute kidney injury †  0/29 (0.00%)  2/234 (0.85%) 
End stage renal disease †  0/29 (0.00%)  1/234 (0.43%) 
Nephrolithiasis †  0/29 (0.00%)  1/234 (0.43%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia aspiration †  0/29 (0.00%)  2/234 (0.85%) 
Bronchospasm †  0/29 (0.00%)  1/234 (0.43%) 
Dyspnea †  0/29 (0.00%)  1/234 (0.43%) 
Pulmonary embolism †  0/29 (0.00%)  1/234 (0.43%) 
Skin and subcutaneous tissue disorders     
Vasculitic ulcer †  0/29 (0.00%)  1/234 (0.43%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   14/29 (48.28%)   68/234 (29.06%) 
Gastrointestinal disorders     
Diarrhea †  10/29 (34.48%)  48/234 (20.51%) 
Flatulence †  4/29 (13.79%)  16/234 (6.84%) 
Nausea †  3/29 (10.34%)  17/234 (7.26%) 
Abdominal pain †  3/29 (10.34%)  15/234 (6.41%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lisa von Moltke, MD, Chief Medical Officer
Organization: Seres Therapeutics
Phone: 617-945-9626
EMail: clinicalstudies@serestherapeutics.com
Layout table for additonal information
Responsible Party: Seres Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03183141    
Other Study ID Numbers: SERES-013
First Submitted: June 8, 2017
First Posted: June 9, 2017
Results First Submitted: March 7, 2023
Results First Posted: March 31, 2023
Last Update Posted: April 10, 2023