Lack of evidence for an unmet need to treat clostridium difficile infection in infants aged
Lack of evidence for an unmet need to treat clostridium difficile infection in infants aged
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.
c.difficile infection, diarrhea, infants, paediatrics, clinical trial
912-918
Faust, S.N.
f97df780-9f9b-418e-b349-7adf63e150c1
Wilcox, M.H.
0e37bce2-f3e5-4349-a7b8-9e4efa689d1a
Banaszkiewicz, A.
7bb4c213-3d5f-4c98-8a11-82a3135ddc21
Bouza, E.
2feed12d-3e4c-40fe-93f7-7debae9ab45c
Raymond, J.
6b73a03f-bd3e-4b28-bfb2-b3f529dab3cd
Gerding, D.N.
b14051e0-57e0-45fa-9528-cff9aabf16ee
15 March 2015
Faust, S.N.
f97df780-9f9b-418e-b349-7adf63e150c1
Wilcox, M.H.
0e37bce2-f3e5-4349-a7b8-9e4efa689d1a
Banaszkiewicz, A.
7bb4c213-3d5f-4c98-8a11-82a3135ddc21
Bouza, E.
2feed12d-3e4c-40fe-93f7-7debae9ab45c
Raymond, J.
6b73a03f-bd3e-4b28-bfb2-b3f529dab3cd
Gerding, D.N.
b14051e0-57e0-45fa-9528-cff9aabf16ee
Faust, S.N., Wilcox, M.H., Banaszkiewicz, A., Bouza, E., Raymond, J. and Gerding, D.N.
(2015)
Lack of evidence for an unmet need to treat clostridium difficile infection in infants aged.
Clinical Infectious Diseases, 60 (6), .
(doi:10.1093/cid/ciu936).
(PMID:25422389)
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.
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More information
Accepted/In Press date: 14 November 2014
e-pub ahead of print date: 24 November 2014
Published date: 15 March 2015
Keywords:
c.difficile infection, diarrhea, infants, paediatrics, clinical trial
Organisations:
Faculty of Medicine
Identifiers
Local EPrints ID: 375911
URI: http://eprints.soton.ac.uk/id/eprint/375911
ISSN: 1058-4838
PURE UUID: c5cd2443-7fca-4d3d-ab5d-7f81b97bac39
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Date deposited: 20 Apr 2015 12:57
Last modified: 15 Mar 2024 03:26
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Contributors
Author:
M.H. Wilcox
Author:
A. Banaszkiewicz
Author:
E. Bouza
Author:
J. Raymond
Author:
D.N. Gerding
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