NCT01533844

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
4 countries

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 4, 2015

Status Verified

March 1, 2015

Enrollment Period

2.5 years

First QC Date

February 13, 2012

Last Update Submit

March 3, 2015

Conditions

Clostridium Difficile

Keywords

CDADNeonatesClostridium difficile

Outcome Measures

Primary Outcomes (1)

  • 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.

    40 days

Study Arms (1)

Neonates

Neonates with CDAD

Eligibility Criteria

AgeUp to 27 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • Subject will be excluded from participation if any of the following apply:
  • Preterm neonates
  • Negative C. difficile toxin test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Site: 3301

Poissy, Paris, 92141, France

Location

Site: 3302

Lyon, 69677, France

Location

Site: 4902

Erlangen, 91054, Germany

Location

Site: 4904

Hanover, 30625, Germany

Location

Site: 4901

Munich, 80337, Germany

Location

Site: 3102

Maastricht, 6229HX, Netherlands

Location

Site: 3403

Granada, 18014, Spain

Location

Site: 3402

Madrid, 28046, Spain

Location

Site: 3401

Valencia, 46026, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool Sample

Study Officials

  • Clinical Study Manager

    Astellas Pharma Europe B.V.

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 15, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 4, 2015

Record last verified: 2015-03

Locations

ES(3)NL(1)FR(2)DE(3)