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Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection (PRISM-EXT)

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ClinicalTrials.gov Identifier: NCT03497806
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2018
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Finch Research and Development LLC.

Brief Summary:

This is an open-label extension of CDI-001 (subsequently referred to as PRISM 3), and is evaluating the safety and efficacy in reducing recurrence of CDI in adults who had a CDI recurrence within 8 weeks of receiving CP101 or placebo in PRISM 3. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in the extension study and administered CP101.

Approximately 70 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.


Condition or disease Intervention/treatment Phase
Clostridium Difficile Recurrent Clostridium Difficile C. Diff C. Difficile Recurrent C. Diff Finch Crestovo Recurrent CDI rCDI CDI Biological: CP101 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : August 1, 2020

Arm Intervention/treatment
Experimental: High Dose CP101
The active ingredient of CP101, Full-Spectrum Microbiota™, is derived from the stools of normal healthy donors who are highly screened, tested, and monitored in a clinically structured donation program.
Biological: CP101
Study drug will be administered at Treatment (Day 1) as an oral dose after cessation of standard-of-care CDI antibiotic treatment of the current episode of recurrent CDI.
Other Name: Full-Spectrum Microbiota™




Primary Outcome Measures :
  1. Proportion of patients with no recurrence of symptomatic, laboratory confirmed C. difficile infection [ Time Frame: Week 8 ]
    Sustained clinical cure rate

  2. Proportion of participants with adverse events as assessed by CTCAE v4.0 [ Time Frame: Week 8 ]
    Mapped to System Organ Class


Secondary Outcome Measures :
  1. Proportion of subjects experiencing recurrent CDI with ribosomal NAP1/BI/027 C. difficile subtype at Week 8 [ Time Frame: 8 weeks ]
    North American Pulse-field type 1 (NAP1)/BI/027 subtyping will be performed if symptoms are consistent with recurrent CDI.

  2. Proportion of subjects experiencing sustained clinical cure at Week 24 [ Time Frame: 24 Weeks ]


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
  1. Ability to provide written informed consent;
  2. Previously enrolled in PRISM 3, had a CDI recurrence within 8 weeks of receiving CP101 or placebo, and have completed their PRISM 3 end of study visit.
  3. An outpatient prior to Treatment
  4. Has received a course of standard-of-care CDI antibiotics for the most recent CDI episode, has had an adequate clinical response, and has completed a washout period.

Exclusion Criteria:

  1. Pregnant, breast-feeding, or considering becoming pregnant during the study
  2. Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
  3. Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
  4. Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
  5. Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
  6. Major intra-abdominal surgery within the past 60 days prior to Screening
  7. Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry
  8. History of total colectomy/ileostomy or bariatric surgery
  9. Planned hospitalization or invasive surgery during the study
  10. Severe acute illness unrelated to CDI

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): NCT03497806


  Show 58 Study Locations
Sponsors and Collaborators
Finch Research and Development LLC.
Medpace, Inc.
Investigators
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Study Director: Zain Kassam, MD, MPH Finch Research and Development LLC.

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Responsible Party: Finch Research and Development LLC.
ClinicalTrials.gov Identifier: NCT03497806     History of Changes
Other Study ID Numbers: CP101-CDI-E02
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Clostridium Infections
Recurrence
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections