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Study Title and Description

Fidaxomicin versus vancomycin for Clostridium difficile infection.



Key Questions Addressed
6 Key Question 6 - Standard Antibiotic treatments
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Primary Publication Information
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TitleData
Title Fidaxomicin versus vancomycin for Clostridium difficile infection.
Author Louie TJ., Miller MA., Mullane KM., Weiss K., Lentnek A., Golan Y., Gorbach S., Sears P., Shue YK.
Country University of Calgary, Calgary, AB, Canada. thomas.louie@albertahealthservices.ca
Year 2011
Numbers Pubmed ID: 21288078
1346 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Key Question 3 - Standard Antibiotic treatments (Tables 9-18, C4-C6)
Arms
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Design Details
Question... Follow Up Answer Follow-up Answer
Region / Funding Source Region: Canada and USA Funding source: Industry The first draft of the manuscript was written by one of the authors who is a part- time employee of the study sponsor, Optimer Pharmaceuticals
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Population / Age or Age Range / % Women / Ethnicity / Inclusion Criteria Population: Adults with acute symptoms of CDI and a positive result on a stool toxin test Mean age: 62 % women: 56 Inclusion criteria: 16 years of age or older with a diagnosis of CDI, defined by the presence of diarrhea (a change in bowel habits, with >3 unformed bowel movements in the 24-hour period before randomization) and C. difficile toxin A, B, or both in a stool specimen obtained within 48 hours before randomization.
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Sample Size (N) / Intervention(s) / Control (s) / Study Duration N=629 Intervention 1: Fidaxomicin 200 mg 2 times/day (n=302) Intervention 2: Vancomycin 125 mg 4 times/day (n=327) Treatment duration: 10 days Followup period: 30 days
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Outcomes Evaluated a. Clinical cure, defined by the resolution of diarrhea (i.e., three or fewer unformed stools for 2 consecutive days), with maintenance of resolution for the duration of therapy and no further requirement (in the investigator’s opinion) for therapy for CDI as of the second day after the end of the course of therapy. b. Clinical recurrence, defined by the reappearance of more than three diarrheal stools per 24-hour period within 4 weeks after the cessation of therapy; C. difficile toxin A or B, or both, in stool; and a need for retreatment for CDI c. Median time to resolution of diarrhea d. All-cause mortality e. Adverse events
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Study Quality Allocation concealment: adeqaute Blinding: double Intention-to-treat analysis: modified (subjects with- drawing before treatment, had ”3 bowel motions in 24 hours, or tested negative for C. difficile toxin were excluded Withdrawals and dropouts reported: yes
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Source of Study Newly Identified Trials
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Baseline Characteristics
No baseline characteristics have been defined for this extraction form.



Results & Comparisons

No Results found.

Quality Dimensions
Dimension Value Notes Comments
Metronidazole trials - Allocation Concealment
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Metronidazole trials - Blinding
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Metronidazole trials - Intention-to-Treat Analysis
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Metronidazole trials - Withdrawals and Dropouts Reported
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Metronidazole trials - Study Quality
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Vancomycin trials - Allocation Concealment
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Vancomycin trials - Blinding
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Vancomycin trials - Intention-to-Treat Analysis
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Vancomycin trials - Withdrawals and Dropouts Reported
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Vancomycin trials - Study Quality
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Quality Rating
No quality rating data was found.