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A Phase II randomized, placebo-controlled, double-blind, dose ranging study of a Clostridium difficile toxoid vaccine (ACAM-CDIFF) in subjects with Clostridium difficile-associated infection(CDI)

Update Il y a 4 ans
Reference: EUCTR2008-004907-69

Woman and Man

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Extract

To compare the event rate of CDI in groups assigned to ACAM-CDIFF vaccine (pooled groups) versus placebo in the 9 week period after the third dose of study vaccine (Study Days 29 to 91) in subjects with primary CDI up to 12 days prior to the first dose of study vaccine, receiving antibiotic standard of care. Primary CDI is defined as a documented, laboratory-confirmed CDI event that is either the first in the subject’s history or is occurring more than 90 days after a prior event.

Inclusion criteria

  • recurrence of Clostridium difficile infection (CDI)

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