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A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (PRISM4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05153499
Recruitment Status : Active, not recruiting
First Posted : December 10, 2021
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
Finch Research and Development LLC.

Brief Summary:
This is a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4). This Phase 3 trial will be conducted in 2 parts: a randomized, double-blind, placebo-controlled trial arm and an optional open-label treatment arm. After completing standard-of-care (SOC) CDI antibiotics for their most recent CDI recurrence, patients who meet all eligibility requirements will be randomized in a 2:1 ratio to receive either CP101 or placebo. Patients will be evaluated for CDI recurrence and safety follow-up through Week 8, the primary endpoint, as well as through Week 24. Patients who qualify may enroll into the optional open label arm if they experience CDI recurrence through week 8.

Condition or disease Intervention/treatment Phase
Recurrent C. Difficile Infection Biological: CP101 Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides Difficile Infection (CDI)
Actual Study Start Date : November 15, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Active Comparator: CP101 Biological: CP101
CP101 is an investigational microbiome therapeutic designed to deliver a complete and functional microbiome to durably repair intestinal dysbiosis, which is being evaluated for the prevention of recurrent CDI.

Placebo Comparator: Placebo Other: Placebo
Placebo




Primary Outcome Measures :
  1. CDI recurrence through week 8 as evidenced by positive toxin EIA or positive toxigenic culture [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Treatment emergent adverse events through week 8 as measure by number of events [ Time Frame: Week 8 ]
  2. CDI recurrence through week 24 as evidenced by positive toxin EIA or positive toxigenic culture [ Time Frame: Week 24 ]
  3. Treatment emergent adverse events through week 24 as measure by number of events [ Time Frame: Week 24 ]

Other Outcome Measures:
  1. Improvement of intestinal microbiome diversity at week 1 as determined by 16S ribosomal ribonucleic acid (rRNA) gene amplicon sequencing [ Time Frame: Week 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent
  • Men or women over 18 years of age or older
  • Current diagnosis of a recurrence of non-severe, non-complicated CDI
  • Subject has a clinical response to standard-of-care CDI antibiotics for the most recent CDI episode
  • History of recurrent CDI defined as:

    • ≥ 3 episodes of CDI, with 2 episodes occurring within the previous 6 months (inclusive of the current episode); OR
    • Patients with a history of 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode) may be eligible if 65 years of age or older.
  • For the Qualifying CDI episode, the following criteria must be satisfied:

    • History of diarrhea (> 3 unformed stools per day) for 2 or more consecutive days that is clinically consistent with CDI. AND
    • Documented positive stool test by local laboratory for toxigenic C. difficile (toxin enzyme immunoassay [EIA] or polymerase chain reaction [PCR]-based testing) for the current CDI episode and within 45 days prior to Randomization. AND
    • Received a course of SOC CDI antibiotics for the most recent CDI episode (for 10 to 21 days, with exact duration, antibiotic type, and dose at the discretion of the Investigator). AND
    • Demonstrated an adequate clinical response, defined as ≤ 3 unformed stools in 24 hours for 2 or more consecutive days during SOC CDI antibiotics prior to Randomization.

Exclusion Criteria:

  • Known stool sample testing positive for enteric pathogen(s) (e.g., Salmonella, Shigella, diarrhoeagenic E. coli, Campylobacter, Giardia) within 28 days prior to Screening
  • Pregnant, breast-feeding, or planning to become pregnant during the trial
  • Historical or current diagnosis of inflammatory bowel disease
  • Recent diagnosis (<6 months prior to screening) of diarrhea-predominant irritable bowel syndrome (post-infection or non-related to an enteric infection)
  • Initiation of any systemic cancer treatment (e.g., chemotherapy, radiotherapy, biologic, immunotherapy, others) for active malignancy
  • Major intra-abdominal surgery (e.g., bowel resection)
  • Known primary or secondary immunodeficiency

Information from the National Library of Medicine

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): NCT05153499


Locations
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Sponsors and Collaborators
Finch Research and Development LLC.
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Responsible Party: Finch Research and Development LLC.
ClinicalTrials.gov Identifier: NCT05153499    
Other Study ID Numbers: FIN-CDI-301
First Posted: December 10, 2021    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Finch Research and Development LLC.:
C. difficile infection
recurrent Clostridium difficile infection
Clostriodioides difficile infection
recurrent C. diff infection
multiple recurrent C. diff infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Recurrence
Disease Attributes
Pathologic Processes