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ART24 for Clostridium Difficile Infection

Phase 1
Waitlist Available
Research Sponsored by Artugen Therapeutics USA, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through the week 12 study visit (cohort a) or week 16 study visit (cohort b)
Awards & highlights

Study Summary

This trial will compare the efficacy of two different dosages of a new drug to placebo in people who have recently had a C. difficile infection and completed standard antibiotic treatment.

Eligible Conditions
  • Clostridium Difficile Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the week 12 study visit (cohort a) or week 16 study visit (cohort b)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through the week 12 study visit (cohort a) or week 16 study visit (cohort b) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess the safety and tolerability of ART24 based on the number of subjects observed with a change from baseline in clinical laboratory tests, vital signs, physical examination.
Assess the safety and tolerability of ART24 based on the percentage of subjects experiencing treatment-emergent adverse events (TEAEs).
Secondary outcome measures
ART24-positive Fecal Samples
Hospitalization for CDI
Recurrence of CDI
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ART24 (Cohort B)Experimental Treatment1 Intervention
In Cohort B, subjects will receive ART24 or placebo daily for 28 days
Group II: ART24 (Cohort A)Experimental Treatment1 Intervention
In Cohort A, subjects will receive ART24 or placebo daily for 7 days
Group III: Placebo (Cohort A)Placebo Group1 Intervention
In Cohort A, subjects will receive ART24 or placebo daily for 7 days
Group IV: Placebo (Cohort B)Placebo Group1 Intervention
In Cohort B, subjects will receive ART24 or placebo daily for 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ART24
2020
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Artugen Therapeutics USA, Inc.Lead Sponsor
Adiso TherapeuticsLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Mustafa Noor, MD, FACPStudy DirectorArtugen Therapeutics USA, Inc.
2 Previous Clinical Trials
324 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)
2020. "A Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04891965.
~7 spots leftby Apr 2025
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