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)

Astellas Pharma Europe B.V.9 sites in 4 countries1 target enrollmentMarch 2012

ConditionsClostridium Difficile

Overview

Phase: N/A
Intervention: Not specified
Conditions: Clostridium Difficile
Sponsor: Astellas Pharma Europe B.V.
Enrollment: 1
Locations: 9
Primary Endpoint: To determine the feasibility of a potential interventional study with fidaxomicin
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

September 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Astellas Pharma Europe B.V.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•Subject will be excluded from participation if any of the following apply:
•Preterm neonates
•Negative C. difficile toxin test

Outcomes

Primary Outcomes

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.