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Study Title and Description

Frequent emergence of resistance in Clostridium difficile during treatment of C. difficile-associated diarrhea with fusidic acid.



Key Questions Addressed
6 Key Question 6 - Standard Antibiotic treatments
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Primary Publication Information
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TitleData
Title Frequent emergence of resistance in Clostridium difficile during treatment of C. difficile-associated diarrhea with fusidic acid.
Author Norén T., Wullt M., Akerlund T., Bäck E., Odenholt I., Burman LG.
Country Department of Infectious Diseases, Orebro University Hospital, S-701 85 Orebro, Sweden. torbjorn.noren@orebroll.se
Year 2006
Numbers Pubmed ID: 16940098
1352 (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: Sweden Funding source: Region Skåne and the Scandinavian Society of Antimicrobial Chemotherapy, and Leo Pharma AB
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Population / Age or Age Range / % Women / Ethnicity / Inclusion Criteria Population: Symptomatic adult inpatients (51%) or outpatients (49%) on enrollment Mean age: 59 % women: 39 Inclusion criteria: age >18 years, lack of hypersensitivity to fusidic acid or metronidazole, a positive C. difficile toxin assay from feces within 6 days before enrolment, and a history of ongoing diarrhea (diarrhea defined as three or more loose stools per day for at least 2 days)
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Sample Size (N) / Intervention(s) / Control (s) / Study Duration N=131 Intervention 1: Metronidazole 400 mg 3 times/day (n=64) Intervention 2: Fusidic acid 250 mg 3 times/day (n=67) Treatment duration: 7 days Followup period: 33 days
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Outcomes Evaluated a. Clinical cure (defined as cessation of diarrhea within 5-8 days of initiating treatment, and clinical failure as persistence of diarrhea on days 5-8) b. Clinical recurrence, defined as the reappearance of diarrhea on days 8-40 in clinically cured patients who had completed 7 days of treatment c. Adverse events
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Study Quality Allocation concealment: adequate (coded containers of identical appearance) Blinding: double Intention-to-treat analysis: no Withdrawals and dropouts reported: 17 (13%)
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Source of Study Trials Included in Cochrane Systematic Review24
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Baseline Characteristics
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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
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