To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis (DAISY)
This study is currently recruiting participants.
Verified October 2012 by Astellas Pharma Inc
Sponsor:
Astellas Pharma Europe BV
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe BV )
ClinicalTrials.gov Identifier:
NCT01533844
First received: February 13, 2012
Last updated: October 18, 2012
Last verified: October 2012
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Purpose
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.
| Condition |
|---|
|
Clostridium Difficile |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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) |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- To determine the feasibility of a potential interventional study with fidaxomicin [ Time Frame: 40 days ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
Stool Sample
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Neonates
Neonates with CDAD
|
Eligibility| Ages Eligible for Study: | up to 27 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Term neonates less than 28 days of age at enrollment, referred to healthcare professionals due to suspected C Difficile Associated Disease (CDAD).
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533844
Contacts
| Contact: Global Clinical Science | +31 (0)71 54 55 878 | contact@nl.astellas.com |
Locations
| France | |
| Site: 3302 | Not yet recruiting |
| Bron Cedex, France, 69677 | |
| Site: 3301 | Not yet recruiting |
| Clamart Cedex, France, 92141 | |
| Germany | |
| Site: 4903 | Not yet recruiting |
| Cologne, Germany, 50735 | |
| Site: 4902 | Recruiting |
| Erlangen, Germany, 91054 | |
| Site: 4901 | Not yet recruiting |
| Munich, Germany, 80337 | |
| Netherlands | |
| Site: 3102 | Not yet recruiting |
| Maastricht, Netherlands, 6229HX | |
| Site: 3101 | Not yet recruiting |
| Rotterdam, Netherlands, 3015GJ | |
| Spain | |
| Site: 3401 | Not yet recruiting |
| Valencia, Spain, 46026 | |
Sponsors and Collaborators
Astellas Pharma Europe BV
Investigators
| Study Chair: | Clinical Study Manager | Astellas Pharma Europe B.V. |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc ( Astellas Pharma Europe BV ) |
| ClinicalTrials.gov Identifier: | NCT01533844 History of Changes |
| Other Study ID Numbers: | 2819-CL-0204 |
| Study First Received: | February 13, 2012 |
| Last Updated: | October 18, 2012 |
| Health Authority: | France: Committee for the Protection of Personnes Germany: Ministry of Work, Health and Social Affairs in North Rhine-Westph Netherlands: Medical Ethics Review Committee (METC) Spain: Comité Ético de Investigación Clínica |
Keywords provided by Astellas Pharma Inc:
|
CDAD Neonates Clostridium difficile |
ClinicalTrials.gov processed this record on May 21, 2013