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Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiotaâ„¢ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
Overall Recruitment Status: Enrolling by invitation
 
Official Title
PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiotaâ„¢ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
 
Region Sponsors
California - Northern
Finch Research and Development LLC
 
Acronym KP IRB No.
PRISM-EXT 1433118
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
(Adult, Oder Adults) with laboratory confirmed C. difficile infection,Clostridium Difficile, Recurrent Clostridium Difficile, C. Diff, C. Difficile, Recurrent C. Diff, Finch, Crestovo, Recurrent CDI, rCDI, CDI
 
Purpose
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 200 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.
 
Detailed Description
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • Ability to provide written informed consent
  • 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
  • An outpatient prior to Treatment
  • 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
  • Pregnant, breast-feeding, or considering becoming pregnant during the study
  • Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
  • Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
  • Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
  • Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
  • Major intra-abdominal surgery within the past 60 days prior to Screening
  • 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
  • History of total colectomy/ileostomy or bariatric surgery
  • Planned hospitalization or invasive surgery during the study
  • Severe acute illness unrelated to CDI

 
Keywords and/or Specific Medical Conditions
  • Bacterial Infections
  • Gram-Positive Bacterial Infections
  • Clostridium Infections
  • Pathologic Processes
  • CP101-CDI-E02
  • PRISM-EXT
  • Disease Attributes
  • Recurrence
  • Gastroenterology
  • Pathology
 
KP Clinical Facility
  • Oakland Medical Center
 
Clinical Area
  • Gastroenterology
  • Pathology


Principal Investigator:
Theodore R Levin, MD
Contact Information:
- Comprehensive Clinical Research Unit KPNC
-510-891-5955
-frederico.l.alves@kp.org
-Oakland Medical Center


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