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Study Title and Description

Clostridium difficile toxoid vaccine in recurrent C. difficile-associated diarrhea.



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 Clostridium difficile toxoid vaccine in recurrent C. difficile-associated diarrhea.
Author Sougioultzis S., Kyne L., Drudy D., Keates S., Maroo S., Pothoulakis C., Giannasca PJ., Lee CK., Warny M., Monath TP., Kelly CP.
Country Gastroenterology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, 02215,USA.
Year 2005
Numbers Pubmed ID: 15765411
1442 (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 Treatment C. difficile Vaccine
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Subject/Study Details Subject 1: Male, age 51 years Subject 2: Female, age 71 years Subject 3: Female, age 33 years All had •3 unformed bowel movements per day for •2 days, associated with a positive stool toxin test for C. difficile (either tissue culture cytotoxin assay or toxin A or B enzyme intramuscularmunoassay) that occurred within 30 days of discontinuation of therapy with metronidazole or oral vancomycin that had been administered for treatment of a prior episode of C. difficile infection
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Interventions C difficile toxoid vaccine form purified toxins A and B, injected intramuscular at the deltoid region on 4 occasions, on days 0, 7, 28, and 56.
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Clinical Diarrhea Outcomes
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C. difficile Toxin, C. difficile Culture, or Other Subjects discontinued treatment with oral vancomycin after their fourth and final inoculation with the C difficile toxoid vaccine One of the 3 subjects did not show increase in serum antitoxin antibodies or serum toxin neutralizing activity
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Adverse Effects (AE) Harms No AE that were definitely or probably related to vaccination. Adverse events that were possibly related to vaccination included a mild headache (subject 1) and mild abdominal pain (subject 2). Subject 2 also reported transient polyarthralgia after the fourth inoculation and later developed atypical polyarthritis with a normal erythrocyte sedimentation rate, a negative rheumatoid factor test, and slightly elevated C-reactive protein. Approxintramuscularately 2 months after completion of the study, a clinical diagnosis of polymyalgia rheumatica was made by a rheumatologist
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Results & Comparisons

No Results found.