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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)

This study has been terminated.
(Terminated due to the fact that the required number of trial subjects was not met.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01533844
First Posted: February 15, 2012
Last Update Posted: March 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
  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)

Further study details as provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):

Primary Outcome Measures:
  • To determine the feasibility of a potential interventional study with fidaxomicin [ Time Frame: 40 days ]
    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

Enrollment: 1
Study Start Date: March 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Neonates
Neonates with CDAD

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 27 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533844


Locations
France
Site: 3301
Poissy, Paris, France, 92141
Site: 3302
Lyon, France, 69677
Germany
Site: 4902
Erlangen, Germany, 91054
Site: 4904
Hanover, Germany, 30625
Site: 4901
Munich, Germany, 80337
Netherlands
Site: 3102
Maastricht, Netherlands, 6229HX
Spain
Site: 3403
Granada, Spain, 18014
Site: 3402
Madrid, Spain, 28046
Site: 3401
Valencia, Spain, 46026
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
  More Information

Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT01533844     History of Changes
Other Study ID Numbers: 2819-CL-0204
First Submitted: February 13, 2012
First Posted: February 15, 2012
Last Update Posted: March 4, 2015
Last Verified: March 2015

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
CDAD
Neonates
Clostridium difficile