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Antibiotic

CRS3123 vs. Vancomycin for Clostridioides Difficile Infection

Phase 2
Waitlist Available
Led By Urs Ochsner, PhD
Research Sponsored by Crestone, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with a primary episode or first recurrence of CDI are eligible
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 40 - day 70
Awards & highlights

Study Summary

This trial is testing two doses of CRS3123 to see if it is safe and effective in treating adults with Clostridium difficile infection (CDI).

Who is the study for?
Adults over 18 with a first-time or initial recurrence of C. difficile infection, showing at least 3 diarrheal stools/day and positive for the bacteria's toxins. They must be expected to survive the study duration with proper treatment.Check my eligibility
What is being tested?
The trial is testing two doses of CRS3123 (200 mg and 400 mg) taken twice daily against vancomycin taken four times daily, focusing on safety, effectiveness in curing the infection, blood levels of CRS3123, and quality of life impacts.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones for antibiotics include digestive issues like nausea or diarrhea, potential allergic reactions, and sometimes more serious effects depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am experiencing my first or second episode of C. diff infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening through day 70
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening through day 70 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Clinical Cure at Test of Cure (TOC) in the Intention to treat (ITT) population
Secondary outcome measures
Clostridium difficile Infection-Daily Symptoms (CDI DaySyms) change from baseline to each post-baseline visit in domain scores (diarrhea symptoms, abdominal symptoms, and systemic/other symptoms) in the Micro-ITT and ME populations
Rate of Clinical cure at Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations
Rate of clinical cure at TOC as assessed by the investigator in the ITT, Micro-ITT, PP, and ME populations
+7 more
Other outcome measures
To assess the effect of CRS3123 on the microbiology, fecal microbiome, and fecal biomarkers of inflammation, to assess microbiological effect, and to evaluate metabolomics
To assess the fecal concentrations of CRS3123 in the CRS3123 200 mg and 400 mg dose groups

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: CRS3123 400 milligramExperimental Treatment1 Intervention
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 6-hour intervals for 10 days. Due to the difference in dosing schedules between CRS3123 (twice a day) and the standard of care vancomycin (four times a day) and appearance of study drugs used in the 3 Arms, placebo will be used to match the total number of capsules in each arm.
Group II: CRS3123 200 milligramExperimental Treatment1 Intervention
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 6-hour intervals for 10 days. Due to the difference in dosing schedules between CRS3123 (twice a day) and the standard of care vancomycin (four times a day) and appearance of study drugs used in the 3 Arms, placebo will be used to match the total number of capsules in each arm.
Group III: Vancomycin 125 milligramActive Control1 Intervention
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CRS3123
2014
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

Crestone, IncLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,268 Previous Clinical Trials
5,481,024 Total Patients Enrolled
Urs Ochsner, PhDPrincipal InvestigatorCrestone, Inc

Media Library

CRS3123 (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04781387 — Phase 2
Clostridioides difficile Infection Clinical Trial 2023: CRS3123 Highlights & Side Effects. Trial Name: NCT04781387 — Phase 2
CRS3123 (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04781387 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has CRS3123 been cleared for use by the FDA?

"CRS3123's safety was rated a 2 because, while there is some evidence backing its safety, there is no data to support efficacy."

Answered by AI

How many sites are currently conducting this trial?

"30 clinical trial sites are currently running this experiment, with locations including Mayo Clinic in Scottsdale, Arizona and St. Jude Clinical Research, LLC in Doral, California."

Answered by AI

Are there any other published papers on CRS3123?

"CRS3123 was first studied in 2021 at the Advanced Clinical Research-Be Well facility. As of now, there are 23 total studies with 1 being currently conducted. Many of these trials take place in Scottsdale, Arizona."

Answered by AI

Are people currently being signed up for this experiment?

"Yes, this study is still open to new patients. It was originally posted on clinicaltrials.gov on January 5th, 2021 and has been updated as recently as October 31st, 2022. There are 108 spots available at 29 different hospitals or clinics."

Answered by AI

Is this an unprecedented clinical trial?

"The only ongoing trial for CRS3123 is located in 30 cities across 2 nations. The first clinical study began in 2021 and was sponsored by Crestone, Inc. In total, 108 patients completed Phase 2 of the drug approval process. Since then, an additional 22 trials have concluded."

Answered by AI

How many people total are enrolled in this experimental program?

"Yes, this is an ongoing trial that was last updated on October 31st, 2022. 29 different medical facilities are looking for a total of 108 patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection
2021. "Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04781387.
~25 spots leftby Apr 2025
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