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|
Primary Publication Information
|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.|
Pubmed ID: 15765411
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)
|Question... Follow Up||Answer||Follow-up Answer|
|Study Focus||Treatment C. difficile Vaccine|
|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|
|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.|
|Clinical Diarrhea Outcomes|
|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|
|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|
Results & Comparisons
No Results found.