Lack of evidence for an unmet need to treat Clostridium difficile infection in infants aged 2 years: expert recommendations on how to address this issue Journal Article

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Authors: Faust, S. N.; Wilcox, M. H.; Banaszkiewicz, A.; Bouza, E.; Raymond, J.; Gerding, D. N.
Article Title: Lack of evidence for an unmet need to treat Clostridium difficile infection in infants aged 2 years: expert recommendations on how to address this issue
Abstract: The role of Clostridium difficile in causing disease in infants is unclear, and the existence of C. difficile infection (CDI) in this population is controversial. As part of the drug licensing process for new CDI therapies, a pediatric investigation plan is required to define studies in infants aged 2 years. This assumes an unmet medical need, even though clinical trials in this age group may not be feasible. Three pharmaceutical companies developing CDI treatments came together to seek advice from a panel of experts. Our unanimous opinion is that the existence of CDI is questionable in infants, and if it exists, is rare. There is therefore no unmet need for CDI treatment in this population. Interventional studies are not feasible with the current level of knowledge, and studies should be limited to noninterventional studies or open-label pharmacokinetic and safety studies to better define CDI in infants.
Journal Title: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Volume: 60
Issue: 6
ISSN: 1537-6591; 1058-4838
Publisher: . Published by Oxford University Press on behalf of the Infectious Diseases Society of America  
Journal Place: United States
Date Published: 2015
Start Page: 912
End Page: 918
Language: eng
DOI/URL:

10.1093/cid/ciu936
Notes: CI: (c) The Author 2014; JID: 9203213; OTO: NOTNLM; 2014/11/24 [aheadofprint]; ppublish