CP101 for Clostridioides difficile (C. diff) Infection

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Clostridioides difficile (C. diff) InfectionCP101 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, CP101, to see if it can prevent recurrent Clostridioides difficile infections (CDI). The trial will have two parts: a randomized, double-blind, placebo-controlled trial arm and an optional open-label treatment arm.

Eligible Conditions
  • Clostridioides difficile (C. diff) Infection

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Week 24

Week 1
Improvement of intestinal microbiome diversity at week 1 as determined by 16S ribosomal ribonucleic acid (rRNA) gene amplicon sequencing
Week 24
CDI recurrence through week 24 as evidenced by positive toxin EIA or positive toxigenic culture
Treatment emergent adverse events through week 24 as measure by number of events
Week 8
CDI recurrence through week 8 as evidenced by positive toxin EIA or positive toxigenic culture
Treatment emergent adverse events through week 8 as measure by number of events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

CP101
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

324 Total Participants · 2 Treatment Groups

Primary Treatment: CP101 · Has Placebo Group · Phase 3

CP101
Biological
ActiveComparator Group · 1 Intervention: CP101 · Intervention Types: Biological
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 24

Who is running the clinical trial?

Finch Research and Development LLC.Lead Sponsor
4 Previous Clinical Trials
338 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The subject responded to the antibiotics used to treat their CDI.
This program is for patients who have had ≥ 3 episodes of CDI in the last 6 months, or for patients who have had 2 episodes of CDI in the last 6 months and are 65 or older.
The person has had diarrhea for more than three days in a row that is consistent with CDI.
The subject received a course of antibiotics for the most recent CDI episode
Demonstrated an adequate clinical response, defined as ≤ 3 unformed stools in 24 hours for 2 or more consecutive days during antibiotics prior to Randomization.
The ability to provide written informed consent is a requirement for participation in this study.
can vote in the election Any person who is 18 years of age or older can vote in the election.
is often based on clinical symptoms alone
The subject had a positive stool test for toxigenic Clostridium difficile within 45 days prior to randomization.