This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent C. difficile infection (CDI) who have completed a standard of care course of CDI antibiotics and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily doses of ART24 or placebo. Subjects will be followed for 6 months after the last dose of study drug.
This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent CDI (primary \[meaning the first occurrence they have had\] or recurrent infection) who have completed a standard of care course of CDI antibiotics (vancomycin, fidaxomicin, or metronidazole administered for 10 to 21 days) and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily doses of ART24 or placebo. Subjects will be followed for 6 months after the last dose of study drug. Subjects will receive study drug in the following 2 sequential cohorts: * Cohort A: ART24 or placebo once daily for 7 days (8 subjects) * Cohort B: ART24 or placebo once daily for 28 days (28 subjects) In each cohort, subjects will be randomized in a ratio of 3 \[active\]:1 \[placebo\]. Subjects who are randomized to active treatment in both cohorts will receive ART24 (5×10\^9 colony-forming units \[CFU\]) daily. Initiation of Cohort B will only occur once the Data Review Committee (DRC) has evaluated blinded safety data (through Week 2) from Cohort A and recommends that the study proceed to the next cohort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
36
Each ART24 capsule will contain lyophilized ART24 and inactive excipients. ART24 will be supplied in a dose strength of 5×10\^9 CFU/capsule. Subjects will receive 1 capsule daily.
Each placebo capsule is identical in appearance, weight, and packaging to ART24 capsules, but will contain only the inactive excipients. Subjects will receive 1 capsule daily.
Palmtree Clinical Research
Palm Springs, California, United States
Gastro Florida
Clearwater, Florida, United States
Doral Medical Research
Assess the safety and tolerability of ART24 based on the percentage of subjects experiencing treatment-emergent adverse events (TEAEs).
The percentage of subjects experiencing a TEAE will be summarized using the MedDRA system organ class and preferred term.
Time frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
Assess the safety and tolerability of ART24 based on the number of subjects observed with a change from baseline in clinical laboratory tests, vital signs, physical examination.
The number of subjects with a change from baseline from normal to abnormal in clinical laboratory test results, vital signs, physical examination will be summarized.
Time frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
Recurrence of CDI
Defined as ≥3 unformed stools (Bristol Scores of 5, 6, or 7) within 24 hours, AND positive stool testing for C. difficile toxin as documented by the central laboratory, AND the need for antibiotic retreatment for CDI diagnosis.
Time frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
Time to CDI Recurrence
Evaluating the time to CDI recurrence (if applicable) relative to the administration of study medication
Time frame: Through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
Hospitalization for CDI
Evaluating the proportion of subjects who are hospitalized due to a CDI recurrence
Time frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
ART24-positive Fecal Samples
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Doral, Florida, United States
Louisiana Research Center
Shreveport, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Mercury Street Medical Group
Butte, Montana, United States
DiGiovanna Institute
Massapequa, New York, United States
NYU Grossman School of Medicine
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
...and 5 more locations
Proportion of subjects with ART24-positive fecal sample assessed at each study visit
Time frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)