This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC-3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction of Clostridioides difficile infection (CDI).
Study was terminated due to sponsor decision. This decision was not related to safety concerns.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
REC-3964 given at a dose of either 500 mg q12h or 250 mg q12h
GANJ - Toms River - Ocean Family Gastroenterology
Toms River, New Jersey, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Number of Participants With Survival Without Recurrence or Requirement for Additional Clostridioides Difficile Infection (CDI) Treatment
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.
Time frame: 8 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Time frame: Up to 8 weeks
Number of Participants With Related TEAEs
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.
Time frame: Up to 8 weeks
Number of Participants With Serious TEAEs
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.
Time frame: Up to 8 weeks
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Number of Participants With TEAEs Leading to Study Drug Discontinuation
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.
Time frame: Up to 8 weeks
Rate of Recurrent Clostridioides Difficile Infection (rCDI)
Recurrent CDI was defined as a new episode of CDI associated with a new positive Clostridioides difficile stool toxin within 8 weeks of the cessation of initial curative treatment. The number of unformed \[types 5-7 on the Bristol stool scale\] bowel movements per day were recorded by the participant in the stool diary in order to identify a new episode of diarrhea. All new episodes of diarrhea were tested for toxigenic Clostridioides difficile to confirm CDI recurrence. The rate of rCDI was defined as the proportion of participants who had the Clostridioides difficile recurrence among randomized participants.
Time frame: 8 weeks
Time to Recurrence of rCDI
Recurrent CDI was defined as a new episode of CDI associated with a new positive Clostridioides difficile stool toxin within 8 weeks of the cessation of initial curative treatment. The number of unformed \[types 5-7 on the Bristol stool scale\] bowel movements per day were recorded by the participant in the stool diary in order to identify a new episode of diarrhea. All new episodes of diarrhea were tested for toxigenic Clostridioides difficile to confirm CDI recurrence. Time to recurrence of rCDI was to be assessed using Kaplan-Meier estimation.
Time frame: Up to 8 weeks
Number of Participants With Severe rCDI
Recurrent CDI was defined as a new episode of CDI associated with a new positive Clostridioides difficile stool toxin within 8 weeks of the cessation of initial curative treatment. The number of unformed \[types 5-7 on the Bristol stool scale\] bowel movements per day were recorded by the participant in the stool diary in order to identify a new episode of diarrhea. All new episodes of diarrhea were tested for toxigenic Clostridioides difficile to confirm CDI recurrence. Severe CDI was defined as CDI with white blood cell count \>15,000 cells/milliliter and/or serum creatinine ≥1.5 milligram/deciliter.
Time frame: Up to 8 weeks
Number of Participants With rCDI Who Had Associated Hospital Admissions
Recurrent CDI was defined as a new episode of CDI associated with a new positive Clostridioides difficile stool toxin within 8 weeks of the cessation of initial curative treatment. The number of unformed \[types 5-7 on the Bristol stool scale\] bowel movements per day were recorded by the participant in the stool diary in order to identify a new episode of diarrhea. All new episodes of diarrhea were tested for toxigenic Clostridioides difficile to confirm CDI recurrence.
Time frame: Up to 8 weeks
Maximum Observed Plasma Concentration (Cmax) of REC-3964
Time frame: Pre-dose, 1 hour, 3 hours, and 6 hours post morning dose on Day 1 and Day 15
Time to Maximum Plasma Concentration (Tmax) of REC-3964
Time frame: Pre-dose, 1 hour, 3 hours, and 6 hours post morning dose on the Day 1 and Day 15
Trough Plasma Concentration (Ctrough) of REC-3964
Time frame: Pre-dose on Day 15