Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin
Completed · Phase 4
Conditions studied: Clostridium Difficile Infection
In brief
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.
Key facts
- Study ID
- NCT01818141
- Run by
- Hartford Hospital
- People needed
- 34
- Starts
- 2012-10-17
- Expected to finish
- 2014-12-15
- Last updated by the study team
- 2017-06-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Hartford Hospital — Hartford, Connecticut, United States
Full record on ClinicalTrials.gov
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