SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI) (ECOSPOR)
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|ClinicalTrials.gov Identifier: NCT02437487|
Recruitment Status : Completed
First Posted : May 7, 2015
Results First Posted : July 26, 2018
Last Update Posted : July 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile||Drug: SER-109 Drug: Placebo||Phase 2|
ECOSPOR is a Phase 2, multicenter, randomized, double blind, placebo controlled clinical study with 2 treatment arms (SER-109 or placebo). Patients who have diarrhea and a positive C. difficile test result on a stool sample, and who have responded to standard of care antibiotic treatment will receive study drug on Day 1.
Those patients who experience a recurrence of CDI up to 8 weeks after SER 109 or placebo treatment will be offered an opportunity to enroll in an open label SER 109 extension study (Study SERES 005).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||October 2016|
SER 109 (1 × 108 SporQs)
SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
Other Name: Purified Eubacterial Spores, Encapsulated
Placebo Comparator: Placebo
Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
- Number of Subjects With CDI Recurrence [ Time Frame: 8 weeks after treatment. ]
- Time to Recurrence of CDI [ Time Frame: Recurrence of CDI up to 24 weeks after treatment. ]Kaplan-Meier estimate of median number of days to recurrence
- Number of Subjects With CDI Recurrence [ Time Frame: 4 Weeks ]
- Number of Subjects With CDI Recurrence [ Time Frame: 12 Weeks ]
- Number of Subjects With CDI Recurrence [ Time Frame: 24 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437487
|Study Director:||Michele Trucksis, Phd, MD||Seres Therapeutics|