← Back to Search

Antibiotic

CRS3123 for Clostridium difficile Infection

Advanced Gastroenterology, Union City, TN

CRS3123 +1 morePhase 2RecruitingLed by Urs Ochsner, PhDResearch Sponsored by Crestone, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

More than or equal to 3 diarrheal stools/day in 24 hours prior to randomization and in the judgment of the investigator that C difficile is the likely causative agent for the diarrhea.

Stool positive for C. difficile GDH plus Toxin A and/or B

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upday 40 - day 70

Awards & highlights

No Placebo-Only Group

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).

Eligible Conditions

Clostridioides difficile (C. difficile) Infection

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

The doctor believes that you won't survive the study's timeframe even with the best medical care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 40 - day 70

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 40 - day 70

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 40 - 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

Rate of Clinical cure at Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations

Rate of early recurrence of Clostridioides difficile infection through Follow up visit 3 (Day 40) in the Micro-ITT and ME populations

Rate of global cure in the Micro-Intent to Treat, Per Protocol and Microbiologically evaluable populations

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH

3,233 Previous Clinical Trials

5,349,208 Total Patients Enrolled

Crestone, IncLead Sponsor

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 , 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