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

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
Fidaxomicin
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hartford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fidaxomicin

Vancomycin

Arm Description

Fidaxomicin 200mg by mouth every 12 hours for 10 days

Vancomycin 125mg by mouth every 6 hours for 10 days

Outcomes

Primary Outcome Measures

C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
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).
C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
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)

Secondary Outcome Measures

Full Information

First Posted
March 19, 2013
Last Updated
May 26, 2017
Sponsor
Hartford Hospital
Collaborators
Optimer Pharmaceuticals LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01818141
Brief Title
Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin
Official Title
An Open-label, Randomized Study to Assess Inhibition of Spore Production in Patients With Clostridium Difficile Infections: Fidaxomicin Versus Vancomycin
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 17, 2012 (Actual)
Primary Completion Date
December 15, 2014 (Actual)
Study Completion Date
December 15, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
Collaborators
Optimer Pharmaceuticals LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open-label
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fidaxomicin
Arm Type
Active Comparator
Arm Description
Fidaxomicin 200mg by mouth every 12 hours for 10 days
Arm Title
Vancomycin
Arm Type
Active Comparator
Arm Description
Vancomycin 125mg by mouth every 6 hours for 10 days
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
Vancomycin 125mg by mouth every 6 hours for 10 days
Intervention Description
Vancomycin 125mg by mouth every 6 hours for 10 days
Intervention Type
Drug
Intervention Name(s)
Fidaxomicin
Other Intervention Name(s)
Fidaxomicin 200mg by mouth every 12 hours for 10 days
Intervention Description
Fidaxomicin 200mg by mouth every 12 hours for 10 days
Primary Outcome Measure Information:
Title
C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
Description
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).
Time Frame
day 10-13
Title
C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
Description
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)
Time Frame
day 10-13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26592763
Citation
Housman ST, Thabit AK, Kuti JL, Quintiliani R, Nicolau DP. Assessment of Clostridium difficile Burden in Patients Over Time With First Episode Infection Following Fidaxomicin or Vancomycin. Infect Control Hosp Epidemiol. 2016 Feb;37(2):215-8. doi: 10.1017/ice.2015.270. Epub 2015 Nov 23.
Results Reference
result

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

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