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Clinical trials in neonatal sepsis.
MedLine Citation:
PMID:  23904558     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Antibiotic licensing studies remain a problem in neonates. The classical adult clinical syndrome-based licensing studies do not apply to neonates, where sepsis is the most common infection. The main obstacle to conducting neonatal antibiotic trials is a lack of consensus on the definition of neonatal sepsis itself and the selection of appropriate endpoints. This article describes the difficulties of the clinical and laboratory definitions of neonatal sepsis and reviews the varying designs of previous neonatal sepsis trials. The optimal design of future trials of new antibiotics will need to be based on pharmacokinetic/pharmacodynamic parameters, combined with adequately powered clinical studies to determine safety and efficacy.
Authors:
Clarissa Oeser; Irja Lutsar; Tuuli Metsvaht; Mark A Turner; Paul T Heath; Mike Sharland
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-7-30
Journal Detail:
Title:  The Journal of antimicrobial chemotherapy     Volume:  -     ISSN:  1460-2091     ISO Abbreviation:  J. Antimicrob. Chemother.     Publication Date:  2013 Jul 
Date Detail:
Created Date:  2013-8-1     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7513617     Medline TA:  J Antimicrob Chemother     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Paediatric Infectious Diseases Research Group, St George's, University of London, London, UK.
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