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. (see Contacts and Locations)
Verified June 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: June 18, 2014
Last verified: June 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: November 2014
Estimated Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 18, 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 August 28, 2014