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)

Trial Profile

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)

Discontinued
Phase of Trial: Phase II

Latest Information Update: 11 Mar 2015

At a glance

  • Drugs Fidaxomicin (Primary)
  • Indications Clostridium infections
  • Focus Therapeutic Use
  • Acronyms DAISY
  • Sponsors Astellas Pharma BV
  • Most Recent Events

    • 03 Mar 2015 Status changed from recruiting to discontinued, according to ClinicalTrials.gov record.
    • 02 Oct 2014 Planned End Date changed from 1 Nov 2014 to 1 Jan 2015 as reported by ClinicalTrials.gov record.
    • 18 Jun 2014 Planned End Date changed from 1 Sep 2014 to 1 Nov 2014 as reported by ClinicalTrials.gov record.
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