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Study Title and Description

A randomized, double-blind study comparing Clostridium difficile immune whey and metronidazole for recurrent Clostridium difficile-associated diarrhoea: efficacy and safety data of a prematurely interrupted trial.



Key Questions Addressed
7 Key Question 7 - Nonstandard intervention for treatment of initial and recurrent CDI
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Primary Publication Information
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TitleData
Title A randomized, double-blind study comparing Clostridium difficile immune whey and metronidazole for recurrent Clostridium difficile-associated diarrhoea: efficacy and safety data of a prematurely interrupted trial.
Author Mattila E., Anttila VJ., Broas M., Marttila H., Poukka P., Kuusisto K., Pusa L., Sammalkorpi K., Dabek J., Koivurova OP., Vähätalo M., Moilanen V., Widenius T.
Country Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital, Finland. eero.mattila@hus.fi
Year 2008
Numbers Pubmed ID: 19086244
1406 (internal)

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


Extraction Form: Key Question 4 - Nonstandard intervention for treatment of initial and recurrent CDI (Tables 19, C9)
Design Details
Question... Follow Up Answer Follow-up Answer
Comparison Nonstandard Intervention Versus Active Control for Recurrent Clostridium difficile infection
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Sample 40 adults with >= 2 episodes of Clostridium difficile infection in past 3 months and stool positive for C. difficile toxin 38 completed the study (95%) Mean age: 61.3 (Clostridium difficile infectionW 56.4 vs. metronidazole 65.7) Gender: Male 47%
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Intervention/ Comparison and Method C. difficile immune whey (CDIW) CDIW 200 ml liquid and placebo tablets three times per day x 14 d (n=18) Metronidazole 400 mg tablets and placebo liquid three times per day x 14 days (n=20) Clostridium difficile culture and toxin on days 0, 14, and 28 followup x 7 days Daily stool and symptom diary daily for 42 days Followup after day 28 used stool and symptom diary only
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Resolution of Clostridium difficile infection (Diarrhea and Clostridium difficile Toxin Positive Stool) Response to study drugs at day 14 Clostridium difficile infectionW: 89% (16/18) Metronidazole: 100% (20/20) No statistical testing reported, Fisher’s Exact test performed by reviewers p=0.22
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Other Outcomes Response to study drugs at day 28 (14 days after treatment) Clostridium difficile infectionW: 61% (11/18) Metronidazole:60% (12/20)
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Study Quality Allocation concealment: not defined Blinding: double Intention-to-treat analysis: no Withdrawals and dropouts adequately described: yes Notes: Sample size not achieved because of bankruptcy of sponsor Although Clostridium difficile culture and toxin were measured and stool diary data collected at day 14, the reported primary endpoint, "response to …study drugs" was not defined nor defined in relation to these measures; the same is true for sustained response at day 28 Secondary outcome of time to treatment failure through day 70 was measured by diarrhea only and not by Clostridium difficile toxin in stool Clostridium difficile infectionW had no local or systemic side effects
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Results & Comparisons

No Results found.

Quality Dimensions
Dimension Value Notes Comments
Allocation Concealment Not defined
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Blinding Double
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Intention-to-Treat Analysis No
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Withdrawals and Dropouts Adequately Described Yes
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Study Quality Fair
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Quality Rating
No quality rating data was found.