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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2015 |
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Main ID: |
NCT01533844 |
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Date of registration:
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13/02/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis
DAISY |
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Scientific title:
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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) |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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1 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01533844 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Germany
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Netherlands
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Spain
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Contacts
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Name:
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Clinical Study Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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Astellas Pharma Europe B.V. |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
27 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Clostridium Difficile
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Primary Outcome(s)
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To determine the feasibility of a potential interventional study with fidaxomicin
[Time Frame: 40 days]
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Secondary ID(s)
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2819-CL-0204
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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