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

Clostridium Difficile Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01818141
• Other study ID #: NICO003785HE
• Status: Recruiting
• Phase: Phase 4
• First received: March 19, 2013
• Last updated: March 21, 2013
• Start date: August 2012
• Est. completion date: September 2013

Study information

• Verified date: March 2013
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Infection

Intervention

Drug:
• Vancomycin
Vancomycin 125mg by mouth every 6 hours for 10 days
• Fidaxomicin
Fidaxomicin 200mg by mouth every 12 hours for 10 days

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Hartford Hospital	Optimer Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in quantity of Clostridium difficile (both vegetative cells and spores) found within the stool of patients	The quantity of C.difficile (vegetative cells and spores) will be determined at day 0, 3-5, 10-13, and 25-30. Those counts at day 3-5, 10-13, and 25-30 will be compared to day 0 to assess change from baseline.	day 0, 3-5, 10-13, 25-30	No