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| Name | Class |
|---|---|
| Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | INDUSTRY |
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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.
The purpose of this study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fidaxomicin | Active Comparator | Fidaxomicin 200mg by mouth every 12 hours for 10 days |
|
| Vancomycin | Active Comparator | Vancomycin 125mg by mouth every 6 hours for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | Vancomycin 125mg by mouth every 6 hours for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | day 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) | day 10-13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26592763 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fidaxomicin | Fidaxomicin 200mg by mouth every 12 hours for 10 days Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days |
| FG001 | Vancomycin | Vancomycin 125mg by mouth every 6 hours for 10 days Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fidaxomicin | Fidaxomicin 200mg by mouth every 12 hours for 10 days Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days |
| BG001 | Vancomycin | Vancomycin 125mg by mouth every 6 hours for 10 days Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | day 10-13 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fidaxomicin | Fidaxomicin 200mg by mouth every 12 hours for 10 days Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David P. Nicolau, PharmD, FCCP, FIDSA | Hartford Hospital | 860-972-3941 | david.nicolau@hhchealth.org |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| D000077732 | Fidaxomicin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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Open-label
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| Fidaxomicin | Drug | Fidaxomicin 200mg by mouth every 12 hours for 10 days |
|
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline total colony forming units (CFU) | Total colony forming units (CFU) of Clostridium difficile per patient at baseline. This is the addition of vegetative cell counts and spore cell counts. | Mean | Standard Deviation | log10 CFU/g stool |
|
| Baseline spores CFU | The count (colony forming units, CFU) of Clostridium difficile spores at baseline stool. | Mean | Standard Deviation | log10 CFU/g stool |
|
| Baseline vegetative cells CFU | Count (colony forming units, CFU) of vegetative Clostridium difficile in baseline stool. | Mean | Standard Deviation | log10 CFU/g stool |
|
|
|
| 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) | Posted | Count of Participants | Participants | day 10-13 |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Vancomycin | Vancomycin 125mg by mouth every 6 hours for 10 days Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days | 0 | 16 | 0 | 16 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061065 | Polyketides |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |