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

  • Interventional
  • Recruiting
  • NCT03497806
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT03497806

IRB#IRB18-0808

Lead SponsorFinch Research and Development LLC.

Lead PhysicianKathleen Mullane

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting