Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin
Status and phase
Completed
Phase 4
Conditions
Clostridium Difficile Infection
Treatments
Drug: Vancomycin
Drug: Fidaxomicin
Details and patient eligibility
About
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.
Full description
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.
Enrollment
34 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
34 participants in 2 patient groups
Fidaxomicin
Active Comparator group
Description:
Fidaxomicin 200mg by mouth every 12 hours for 10 days
Treatment:
Drug: Fidaxomicin
Vancomycin
Active Comparator group
Description:
Vancomycin 125mg by mouth every 6 hours for 10 days
Treatment:
Drug: Vancomycin
Trial contacts and locations
1
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems