Trials / Terminated
TerminatedNCT01533844
To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis
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)
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 1 (actual)
- Sponsor
- Astellas Pharma Europe B.V. · Industry
- Sex
- All
- Age
- 27 Days
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2014-09-01
- Completion
- 2014-09-01
- First posted
- 2012-02-15
- Last updated
- 2015-03-04
Locations
9 sites across 4 countries: France, Germany, Netherlands, Spain
Source: ClinicalTrials.gov record NCT01533844. Inclusion in this directory is not an endorsement.