Phase 4
Completed N=34
Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin
Clostridium Difficile Infection
Source: ClinicalTrials.gov NCT01818141 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool — 11; 6 Participants
◆ Published Evidence
Established
32citations · ~3 / year
Assessment of Clostridium difficile Burden in Patients Over Time With First Episode Infection Following Fidaxomicin or Vancomycin.
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.
Linked Publications
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Assessment of Clostridium difficile Burden in Patients Over Time With First Episode Infection Following Fidaxomicin or Vancomycin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool |
11; 6 | — |
| PRIMARY C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool |
4; 5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01818141) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.