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

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ClinicalTrials.gov Identifier: NCT01818141
Recruitment Status : Completed
First Posted : March 26, 2013
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Optimer Pharmaceuticals LLC
Information provided by (Responsible Party):
Hartford Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: Vancomycin Drug: Fidaxomicin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open-label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized Study to Assess Inhibition of Spore Production in Patients With Clostridium Difficile Infections: Fidaxomicin Versus Vancomycin
Actual Study Start Date : October 17, 2012
Actual Primary Completion Date : December 15, 2014
Actual Study Completion Date : December 15, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fidaxomicin
Fidaxomicin 200mg by mouth every 12 hours for 10 days
Drug: Fidaxomicin
Fidaxomicin 200mg by mouth every 12 hours for 10 days
Other Name: Fidaxomicin 200mg by mouth every 12 hours for 10 days

Active Comparator: Vancomycin
Vancomycin 125mg by mouth every 6 hours for 10 days
Drug: Vancomycin
Vancomycin 125mg by mouth every 6 hours for 10 days
Other Name: Vancomycin 125mg by mouth every 6 hours for 10 days




Primary Outcome Measures :
  1. C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool [ Time Frame: day 10-13 ]
    The number and percentage of patients who achieved at least 2 log10 colony forming units (CFU)/g of stool reductions of Clostridium difficile spores from baseline by the end of therapy (days 10-13).

  2. C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool [ Time Frame: day 10-13 ]
    The number and percentage of patients who achieved at least 2 log10 CFU/g of stool reductions of Clostridium difficile vegetative cells from baseline by the end of therapy (days 10-13)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818141


Locations
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United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
Hartford Hospital
Optimer Pharmaceuticals LLC

Publications of Results:
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Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01818141     History of Changes
Other Study ID Numbers: NICO003785HE
First Posted: March 26, 2013    Key Record Dates
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Fidaxomicin
Anti-Bacterial Agents
Anti-Infective Agents