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NCT01533844 Clinical Trial

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

Clostridium Difficile Clinical Trial

— DAISY  

Official title:
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)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01533844
Other study ID # 2819-CL-0204
Secondary ID
Status Terminated
Phase N/A
First received February 13, 2012
Last updated March 3, 2015
Start date March 2012
Est. completion date September 2014

Study information
Verified date March 2015
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesGermany: Ministry of Work, Health and Social Affairs in North Rhine-WestphNetherlands: Medical Ethics Review Committee (METC)Spain: Comité Ético de Investigación Clínica
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 27 Days
Eligibility 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

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Site: 3302 Lyon
France Site: 3301 Poissy Paris
Germany Site: 4902 Erlangen
Germany Site: 4904 Hanover
Germany Site: 4901 Munich
Netherlands Site: 3102 Maastricht
Spain Site: 3403 Granada
Spain Site: 3402 Madrid
Spain Site: 3401 Valencia

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

France,  Germany,  Netherlands,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 40 days No
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