To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis (DAISY)
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ClinicalTrials.gov Identifier: NCT01533844
Recruitment Status :
(Terminated due to the fact that the required number of trial subjects was not met.)
First Posted : February 15, 2012
Last Update Posted : March 4, 2015
Astellas Pharma Europe B.V.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
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.
An Observational, Non-interventional Study to Determine the Role of Clostridium Difficile in the Pathogenesis of Disease Observed in Neonates and to Investigate the Feasibility of a Potential Study to Evaluate Safety, Efficacy and Pharmacokinetics of Fidaxomicin Oral Suspension in Neonates With Clostridium Difficile Associated Disease (CDAD)
To determine the feasibility of a potential interventional study with fidaxomicin [ Time Frame: 40 days ]
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.
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Ages Eligible for Study:
up to 27 Days (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Term neonates less than 28 days of age at enrollment, referred to healthcare professionals due to suspected C Difficile Associated Disease (CDAD).
Subject is suffering from diarrhea or other signs or symptoms consistent with CDAD (as described in section 5.2.3)
Presence of either toxin A or B (or both) of C. difficile in the stool within 24 hours prior to enrollment using the C. difficile Quik Chek Complete® diagnostic test, provided by the sponsor
Subject will be excluded from participation if any of the following apply: