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) (DAISY)

NCT01533844 TERMINATED

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.

Details

Lead sponsor	Astellas Pharma Europe B.V.
Status	TERMINATED
Enrolment	1
Start date	2012-03
Completion	2014-09

Conditions

• Clostridium Difficile

Primary outcomes

• To determine the feasibility of a potential interventional study with fidaxomicin — 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.

Countries

France, Germany, Netherlands, Spain