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Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The purpose of this study is to provide access to SER-109 for adult subjects with recurrent Clostridioides Difficile Infection (RCDI) and to monitor subject safety and report to regulatory authorities, as appropriate.
Full description
SERES-016 is a multicenter, expanded-access program (EAP) of SER-109 for subjects with RCDI conducted in the US. Up to approximately 90 subjects are expected to be treated with SER-109, or until SER-109 investigational product is exhausted. Within 3 days after end of antibiotics and on the day preceding SER-109, a bowel cleanse should be administered.
Subjects who meet all the inclusion criteria and none of the exclusion criteria are eligible for participation in the EAP. Each subject (or subject's legally authorized representative) will have to sign an informed consent form (ICF) indicating their consent to participate in the EAP.
Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days.
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Inclusion and exclusion criteria
Main Inclusion Criteria:
Signed informed consent prior to initiation of any EAP-specific procedure or treatment. The subject, or their legally authorized representative, must be willing to provide written informed consent and understand the potential risks and benefits from EAP enrollment and treatment.
≥2 episodes of CDI inclusive of the current episode
The CDI recurrence must have met the protocol definition of:
Main Exclusion Criteria:
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Data sourced from clinicaltrials.gov
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