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Macrolide Antibiotic

Fidaxomicin for Clostridium Difficile Infection

Phase 4
Waitlist Available
Research Sponsored by Hartford Hospital
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 day 10-13
Awards & highlights

Study Summary

The purpose of this study is to compare number of vegetative cells and spores in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection.

Eligible Conditions
  • Clostridium Difficile Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 10-13
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 10-13 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool

Trial Design

2Treatment groups
Active Control
Group I: FidaxomicinActive Control1 Intervention
Fidaxomicin 200mg by mouth every 12 hours for 10 days
Group II: VancomycinActive Control1 Intervention
Vancomycin 125mg by mouth every 6 hours for 10 days

Find a Location

Who is running the clinical trial?

Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry Sponsor
7 Previous Clinical Trials
2,481 Total Patients Enrolled
Optimer Pharmaceuticals LLCIndustry Sponsor
7 Previous Clinical Trials
2,481 Total Patients Enrolled
Hartford HospitalLead Sponsor
135 Previous Clinical Trials
19,052 Total Patients Enrolled
~3 spots leftby Jun 2025
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