NCT06536465Phase 2Terminated

The Clostridioides Difficile Trial of REC-3964

Study sponsor: Recursion Pharmaceuticals Inc. · RXRX

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-05-06Actual

Enrollment · participants3Actual

Source updated2025-11-17Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-11-17 · 1 field changed

Main study measure wording changed

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− Before

Measure: Number of Participants ~~with~~ Survival Without Recurrence or Requirement for Additional CDI Treatment Measure: Number of Participants ~~with~~ Treatment-emergent Adverse Events (TEAEs) Measure: Number of Participants ~~with~~ Related TEAEs Measure: Number of Participants ~~with~~ Serious TEAEs Measure: Number of Participants ~~with~~ TEAEs Leading to Study Drug Discontinuation

+ After

Measure: Number of Participants With Survival Without Recurrence or Requirement for Additional Clostridioides Difficile Infection (CDI) Treatment Measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Measure: Number of Participants With Related TEAEs Measure: Number of Participants With Serious TEAEs Measure: Number of Participants With TEAEs Leading to Study Drug Discontinuation

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Study details

Conditions studied

Recurrent Clostridioides Difficile Infection

Treatments or interventions studied

REC-3964Drug

Primary outcomes · main study measures

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measure: Number of Participants With Survival Without Recurrence or Requirement for Additional Clostridioides Difficile Infection (CDI) Treatment; description: Recurrent CDI was defined as a new episode of CDI associated with a new positive Clostridioides difficile stool toxin or requirement for additional CDI treatment during the 8-week Follow-up Period after cure of preceding CDI with initial curative treatment.; timeFrame: 8 weeks; measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs); description: A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.; timeFrame: Up to 8 weeks; measure: Number of Participants With Related TEAEs; description: A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An Investigator who was qualified in medicine determined relationship to the study drug for each AE (unrelated or related). The Investigator decided whether, in his or her medical judgment, if there was a reasonable biological possibility that the event may have been caused by the study drug.; timeFrame: Up to 8 weeks; measure: Number of Participants With Serious TEAEs; description: A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A Serious TEAE was defined as results in death, immediately life-threatening, requires in-participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity in conducting activities of daily living for at least 28 days, results in a congenital abnormality or birth defect, or an important medical event that may jeopardize the participant or may require medical intervention.; timeFrame: Up to 8 weeks; measure: Number of Participants With TEAEs Leading to Study Drug Discontinuation; description: A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.; timeFrame: Up to 8 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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