Clostridium Difficile Infection
Conditions
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.
Interventions
DRUGVancomycin
Vancomycin 125mg by mouth every 6 hours for 10 days
DRUGFidaxomicin
Fidaxomicin 200mg by mouth every 12 hours for 10 days
Sponsors
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Hartford Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool | 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). |
| C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fidaxomicin Fidaxomicin 200mg by mouth every 12 hours for 10 days
Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days | 18 |
| Vancomycin Vancomycin 125mg by mouth every 6 hours for 10 days
Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days | 16 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | No baseline C.diff colonies | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Vancomycin | Total | Fidaxomicin |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 15 | 67 years STANDARD_DEVIATION 15 | 69 years STANDARD_DEVIATION 15 |
| Baseline spores CFU | 4.87 log10 CFU/g stool STANDARD_DEVIATION 1.43 | 4.94 log10 CFU/g stool STANDARD_DEVIATION 1.47 | 5.00 log10 CFU/g stool STANDARD_DEVIATION 1.44 |
| Baseline total colony forming units (CFU) | 4.96 log10 CFU/g stool STANDARD_DEVIATION 1.81 | 5.19 log10 CFU/g stool STANDARD_DEVIATION 1.8 | 5.41 log10 CFU/g stool STANDARD_DEVIATION 1.72 |
| Baseline vegetative cells CFU | 4.22 log10 CFU/g stool STANDARD_DEVIATION 2.1 | 4.23 log10 CFU/g stool STANDARD_DEVIATION 2.3 | 4.23 log10 CFU/g stool STANDARD_DEVIATION 2.39 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 31 Participants | 16 Participants |
| Region of Enrollment United States | 16 participants | 34 participants | 18 participants |
| Sex: Female, Male Female | 9 Participants | 20 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 |
Outcome results
Primary
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).
Time frame: day 10-13
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fidaxomicin | C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool | 11 Participants |
| Vancomycin | C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool | 6 Participants |
Primary
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)
Time frame: day 10-13
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fidaxomicin | C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool | 4 Participants |
| Vancomycin | C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool | 5 Participants |