To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis (DAISY)

Astellas

Status: Terminated

Conditions: Clostridium Difficile

Study type: Observational

Funder types: Industry

Identifiers

NCT01533844

2819-CL-0204

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: Under 27 days old

Volunteers: No Healthy Volunteers

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

Trial design

1 participants in 1 patient group

Neonates

Description:

Neonates with CDAD