An observational study in Clostridium Difficile, sponsored by Astellas Pharma Europe B.V.. Terminated at 9 sites in 4 countries. Open to participants aged Up to 27 Days. Per ClinicalTrials.gov, last updated 2015-03-04.
Sponsored by Astellas Pharma Europe B.V. · Observational
The objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin. The incidence and clinical aspects of Clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.
310 studies on the registry are indexed under Clostridium Infections; 50 are open to participants now.
This study's enrollment of 1 is below the median of 214 across 58 observational studies indexed under Clostridium Infections.
Browse Clostridium Infections studies →Astellas Pharma Europe B.V. is the lead sponsor of 93 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Term neonates less than 28 days of age at enrollment, referred to healthcare professionals due to suspected C Difficile Associated Disease (CDAD).
Exclusion Criteria:
Subject will be excluded from participation if any of the following apply:
Neonates with CDAD
To determine the feasibility of a potential interventional study with fidaxomicin
The incidence and clinical aspects of clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.
Time frame: 40 days
This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Europe B.V.