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

Information source: Hartford Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clostridium Difficile Infection

Intervention: Vancomycin (Drug); Fidaxomicin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hartford Hospital

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.

Clinical Details

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

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

Primary outcome: The change in quantity of Clostridium difficile (both vegetative cells and spores) found within the stool of patients

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Hartford Hospital, Hartford, Connecticut 06102, United States; Recruiting
David P Nicolau, PharmD, Phone: 860-545-3941, Email: dnicola@harthosp.org
David P Nicolau, PharmD, Principal Investigator
Seth T Housman, PharmD, Sub-Investigator
Additional Information

Starting date: August 2012
Last updated: March 21, 2013

Page last updated: August 23, 2015

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