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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
Pivotal Trial
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
138 Previous Clinical Trials
19,363 Total Patients Enrolled
~3 spots leftby Nov 2025
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