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Study Title and Description

Open-label, dose escalation phase I study in healthy volunteers to evaluate the safety and pharmacokinetics of a human monoclonal antibody to Clostridium difficile toxin A.



Key Questions Addressed
8 Key Question 8 - Case studies/series and potential harms of nonstandard interventions for CDI
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Primary Publication Information
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TitleData
Title Open-label, dose escalation phase I study in healthy volunteers to evaluate the safety and pharmacokinetics of a human monoclonal antibody to Clostridium difficile toxin A.
Author Taylor CP., Tummala S., Molrine D., Davidson L., Farrell RJ., Lembo A., Hibberd PL., Lowy I., Kelly CP.
Country Beth Israel Deaconess Medical Center, University of Massachusetts Medical School, Boston, Massachusetts, USA.
Year 2008
Numbers Pubmed ID: 18502001
1440 (internal)

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


Extraction Form: Key Question 4 - Case studies/series and potential harms of nonstandard interventions for CDI (Table C11)
Design Details
Question... Follow Up Answer Follow-up Answer
Study Focus Phase 2 safety study
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Subject/Study Details 30 subjects, mean age 27.5 years (range 20- 53) 33% male 5 cohorts of 6 subjects each
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Interventions Monoclonal antibody to C. difficile toxin A (C. difficileAI)
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Clinical Diarrhea Outcomes
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C. difficile Toxin, C. difficile Culture, or Other
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Adverse Effects (AE) Harms No serious AEs possibly, probably or definitely associated to C. difficile infection 3 moderate severity AEs (low BP, diarrhea) 18 mild severity (headache, nausea, loose stools, abdominal discomfort, BP changes)
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Results & Comparisons

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