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 March 2014 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT01533844
First received: February 13, 2012
Last updated: March 12, 2014
Last verified: March 2014
  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: 20
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (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: 3301 Recruiting
Poissy, Paris, France, 92141
Site: 3302 Recruiting
Lyon, France, 69677
Germany
Site: 4903 Withdrawn
Cologne, Germany, 50735
Site: 4902 Recruiting
Erlangen, Germany, 91054
Site: 4904 Recruiting
Hanover, Germany, 30625
Site: 4901 Recruiting
Munich, Germany, 80337
Netherlands
Site: 3102 Recruiting
Maastricht, Netherlands, 6229HX
Site: 3101 Withdrawn
Rotterdam, Netherlands, 3015GJ
Spain
Site: 3403 Recruiting
Granada, Spain, 18014
Site: 3402 Recruiting
Madrid, Spain, 28046
Site: 3401 Recruiting
Valencia, Spain, 46026
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier: NCT01533844     History of Changes
Other Study ID Numbers: 2819-CL-0204
Study First Received: February 13, 2012
Last Updated: March 12, 2014
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 April 17, 2014