Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00008995

Trial Description

start of 1:1-Block title

Title

A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

SUNSHINE

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The purpose of this study is to investigate the clinical response to fidaxomicin oral
suspension or tablets and vancomycin oral liquid or capsules in pediatric subjects with
Clostridium difficile-associated diarrhea (CDAD). It will also investigate the
recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well
as acceptance of the fidaxomicin oral suspension formulation.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008995
  •   2015/07/31
  •   2014/08/11
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2013-000508-40 
  •   NCT02218372  (ClinicalTrials.gov)
  •   2819-CL-0202  (Astellas Pharma Europe B.V.)
  •   2013-000508-40 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Clostridium Difficile-associated Diarrhea (CDAD)
  •   A04.7 -  Enterocolitis due to Clostridium difficile
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: Fidaxomicin
  •   Drug: Vancomycin
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Confirmed clinical response based on the assessment by the investigator; time frame: up to 14 days; For subjects from Birth to < 2 years, defined as: Absence of watery diarrhea for 2 consecutive days during treatment and subjects remain well until the time of study drug discontinuation (initial clinical response). In addition, subjects should not require further CDAD therapy within 2 days after completion of the study drug (confirmed clinical response).
For subjects aged ≥ 2 years to < 18 years, defined as: Improvement in the number and character of bowel movements as determined by < 3 unformed bowel movements (UBMs) per day for 2 consecutive days during treatment and subjects remain well until the time of study drug discontinuation (initial clinical response). In addition, subjects should not require further CDAD therapy within 2 days after completion of the study drug (confirmed clinical response).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Sustained clinical response at the end of study; time frame: up to 42 days; Defined as confirmed clinical response (end of treatment [EOT] + 2 days) without CDAD recurrence until the time of assessment during the Follow-up period.
- Sustained clinical response 14 days after confirmation clinical response; time frame: up to 28 days
- Time to resolution of diarrhea; time frame: Up to 10 days; For subjects from Birth to < 2 years, defined as: the time elapsing (in hours rounded up from minutes > 30) from the start of treatment (time of first dose of study medication) to resolution of diarrhea (time of last episode of watery diarrhea the day prior to the first of 2 consecutive days without watery diarrhea that was sustained through EOT). For subjects aged ≥ 2 years to < 18 years, defined as: the time elapsing (in hours rounded up from minutes > 30) from the start of treatment (time of first dose of study medication) to resolution of diarrhea (time of the last UBM the day prior to the first of 2 consecutive days of < 3 UBMs that are sustained through EOT).
- Recurrence of Clostridium difficile-associated Diarrhea (CDAD) during or at the end of the Follow-up period; time frame: up to 42 days; For subjects from Birth to < 2 years, defined as: the re-establishment of watery diarrhea after confirmed clinical response to an extent that is greater than that noted on the last day of study drug with the demonstration of a positive direct or indirect testing for the presence of toxigenic C.difficile in stool and that, in the investigator's opinion, would require retreatment with CDAD anti-infective therapy. For subjects aged ≥ 2 years < 18 years, defined as: the re-establishment of diarrhea after confirmed clinical response to an extent (as measured by the frequency of passed unformed stools) that is greater than that noted on the last day of study drug with the demonstration of a positive direct or indirect testing for the presence of toxigenic C.difficile in stool and that, in the investigator's opinion, would require retreatment with CDAD anti-infective therapy.
- Time to recurrence during or at the end of the Follow-up period; time frame: up to 42 days

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   Belgium
  •   Canada
  •   France
  •   Germany
  •   Hungary
  •   Italy
  •   Poland
  •   Romania
  •   Slovakia
  •   Spain
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2014/10/31
  •   144
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   17   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Subject is diagnosed with CDAD according to local diagnostic criteria. As a minimum
there must be positive detection, within 72 hours prior to randomization, of either
toxin A and/or toxin B in stool or positive detection of toxigenic C. difficile in
stool and:

- Subject from Birth to < 2 years: watery diarrhea in the 24 hours prior to
screening.

- Subject ≥ 2 years to < 18 years: ≥ 3 unformed bowel movements in the 24 hours
prior to screening.

- For subjects < 5 years: Negative rotavirus test.

- Female subject of childbearing potential:

- must have a negative urine pregnancy test at Screening, and

- must abstain from sexual activity for the duration of the study, or

- must use two forms of birth control (at least one of which must be a barrier
method) starting at Screening and throughout the study period and for 28 days
after the final study drug administration.

- Female subject must not be breastfeeding at Screening or during the study period, and
for 28 days after the final study drug administration.

- Female subject must not donate ova starting at Screening and throughout the study
period, and for 28 days after the final study drug administration.

- Subject agrees not to participate in another interventional study while in the study
(with the exception of studies as described in exclusion criteria below).

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Concurrent use of metronidazole, oral vancomycin or any other antibiotic treatments
for CDAD. If the investigator feels the clinical imperative is to begin treatment
before knowing the laboratory result for toxigenic C. difficile, up to four doses but
no more than 24 hours of treatment with metronidazole, oral vancomycin or any other
effective treatment for CDAD are allowed.

- Subject has pseudomembranous colitis, fulminant colitis, toxic megacolon or ileus.

- Subject has a history of inflammatory bowel disease (e.g., ulcerative colitis or
Crohn's disease etc.).

- Subject has diarrhea caused by an agent other than C. difficile (e.g. infections,
infestations, drugs etc.).

- Subject has known hypersensitivity to fidaxomicin, vancomycin or their excipients or
to teicoplanin.

- Subject has received an investigational therapy within 28 days, prior to Screening,
with the exception of studies with primary treatment for cancer without novel
Investigational Medicinal Product (IMP) and which do not affect the assessment of
diarrhea.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Astellas Pharma Europe B.V.
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Merck Sharp & Dohme Corp.
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Astellas Pharma Europe B.V.
    • Clinical Research Physician 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Global Clinical Science 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   105
  •   2015/08/05
* This entry means the parameter is not applicable or has not been set.