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

Terminated

• Conditions: Clostridium Difficile

• Registration Number: NCT01533844
• Lead Sponsor: Astellas Pharma Europe B.V.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-13
• Study First Posted: 2012-02-15
• Study Start: 2012-03
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-03
• Last Update Posted: 2015-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (9)

Site: 4904; 🇩🇪 Hanover, Germany

Site: 3301; 🇫🇷 Poissy, Paris, France

Site: 4902; 🇩🇪 Erlangen, Germany

Site: 3302; 🇫🇷 Lyon, France

Site: 4901; 🇩🇪 Munich, Germany

Site: 3102; 🇳🇱 Maastricht, Netherlands

Site: 3403; 🇪🇸 Granada, Spain

Site: 3402; 🇪🇸 Madrid, Spain

Site: 3401; 🇪🇸 Valencia, Spain