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

Astellas Pharma Europe B.V.1 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Clostridium Difficile

Eligibility

Sex: ALLMax age: 27 Days

Medical Language ↔ Plain English

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

Locations (9)

Site: 3301

Poissy, Paris, France

Site: 3302

Lyon, France

Site: 4902

Erlangen, Germany

Site: 4904

Hanover, Germany

Outcomes

Primary Outcomes

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.

Time frame: 40 days

Data from ClinicalTrials.gov

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