Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin

Study Overview
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Brief Summary
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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.

Detailed Description
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The purpose of this study is to: Compare quantitatively the number of vegetative cells in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection Compare quantitatively the number of spores in the stool over time for patients presenting with their first episode of C. difficile infection having been treated with either fidaxomicin or vancomycin.

Official Title
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An Open-label, Randomized Study to Assess Inhibition of Spore Production in Patients With Clostridium Difficile Infections: Fidaxomicin Versus Vancomycin

Conditions
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Clostridium Difficile Infection

Intervention / Treatment
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* Drug: Vancomycin
* Drug: Fidaxomicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and above First diagnosis of C. difficile infection Treatment for C. difficile infection less than 24 hours Female subjects must be nonpregnant, nonlactating, and either postmenopausal for at least 1 year, surgically sterile (i.e., documented tubal ligation or hysterectomy) for at least 90 days, abstinent, or agree to use 1 of the following forms of contraception from the time of signing the Informed Consent form (ICF) until 30 days after leaving the study site: a nonhormonal intrauterine device (IUD) with spermicide, female condom with spermicide, contraceptive sponge with spermicide, diaphragm with spermicide, cervical cap with spermicide, a male sexual partner who agrees to use a male condom with spermicide, or a sterile sexual partner. Exclusion Criteria: History of hypersensitivity to fidaxomicin or vancomycin Pregnant or breast-feeding Active treatment with other therapies with activity against C. difficile Receiving any peristaltic agents Medical history including ulcerative colitis or Chron's disease Ordered to be nothing by mouth or cannot swallow the study medication Participation in another clinical research study utilizing pharmacological treatment within 1 month or five half-lives of the medication whichever is longer Any other reason felt by the investigator to potentially affect the outcomes of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fidaxomicin<br>Fidaxomicin 200mg by mouth every 12 hours for 10 days | Drug: Fidaxomicin<br>* Fidaxomicin 200mg by mouth every 12 hours for 10 days<br>* Other names: Fidaxomicin 200mg by mouth every 12 hours for 10 days;|
| Active Comparator: Vancomycin<br>Vancomycin 125mg by mouth every 6 hours for 10 days | Drug: Vancomycin<br>* Vancomycin 125mg by mouth every 6 hours for 10 days<br>* Other names: Vancomycin 125mg by mouth every 6 hours for 10 days;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool | The number and percentage of patients who achieved at least 2 log10 colony forming units (CFU)/g of stool reductions of Clostridium difficile spores from baseline by the end of therapy (days 10-13). | day 10-13 | 
| C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool | The number and percentage of patients who achieved at least 2 log10 CFU/g of stool reductions of Clostridium difficile vegetative cells from baseline by the end of therapy (days 10-13) | day 10-13 |