Study Title and Description
A double-blind randomized controlled trial of fusidic acid and metronidazole for treatment of an initial episode of Clostridium difficile-associated diarrhoea.
Key Questions Addressed
|6||Key Question 6 - Standard Antibiotic treatments|
Primary Publication Information
|Title||A double-blind randomized controlled trial of fusidic acid and metronidazole for treatment of an initial episode of Clostridium difficile-associated diarrhoea.|
|Author||Wullt M., Odenholt I.|
|Country||Department of Infectious Diseases, University Hospital, Malmö, Sweden. firstname.lastname@example.org|
Pubmed ID: 15163651
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)
No arms have been defined in this extraction form.
|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|
|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)|
|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|
|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|
|Study Quality||Allocation concealment: adequate (coded containers of identical appearance) Blinding: double Intention-to-treat analysis: no Withdrawals and dropouts reported: 17 (13%)|
|Source of Study||Trials Included in Cochrane Systematic Review24|
No baseline characteristics have been defined for this extraction form.
Results & Comparisons
No Results found.
|Metronidazole trials - Allocation Concealment|
|Metronidazole trials - Blinding|
|Metronidazole trials - Intention-to-Treat Analysis|
|Metronidazole trials - Withdrawals and Dropouts Reported|
|Metronidazole trials - Study Quality|
|Vancomycin trials - Allocation Concealment|
|Vancomycin trials - Blinding|
|Vancomycin trials - Intention-to-Treat Analysis|
|Vancomycin trials - Withdrawals and Dropouts Reported|
|Vancomycin trials - Study Quality|
No quality rating data was found.