Trial document




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  DRKS00005335

Trial Description

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Title

Multicenter, prospective cohort study on microbiota-defined and clinical risk factors for Clostridium difficile colonization and -associated disease in patient groups at risk

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The main objective of the study is the identification of risk factors for colonization or disease caused by Clostridium difficile by analysis of the microbiota and clinical factors in patients having an increased risk due to underlying diseases

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Brief Summary in Scientific Language

Multicenter, prospective cohort study on microbiota-defined and clinical risk factors for Clostridium difficile colonization and -associated disease in patient groups at risk

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005335
  •   2013/10/14
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  •   yes
  •   Approved
  •   6444, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   U1111-1211-2338 
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Health Condition or Problem studied

  •   A04.7 -  Enterocolitis due to Clostridium difficile
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Interventions/Observational Groups

  •   Questionaire, patient questionaire, stool sample
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Proportion of patients with C. difficile colonization and -associated disease

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Secondary Outcome

Proportion of patients with CDAD, microbial pattern at baseline and at the final visit in colonized patients, microbial pattern at baseline and at the final visit in CDAD patients, disease course (severity, complications, recurrences) of CDAD, IgA and IgG repertoires in blood and intestinal mucosal samples

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/10/21
  •   2000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inpatients with underlying diseases causing in increased risk of C. difficile colonization/CDAD: a) malignant disease, b) s/p stem cell or solid organ transplantation, c) infiammatory bowel disease, d) hemodialysis, written informed consent

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Exclusion Criteria

CDAD or suspected CDAD within 30 days prior to enrollment; diseases which prevent candidates to understand the nature and the consequences of the clinical trial; indications for protocol non-compliance

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Addresses

  • start of 1:1-Block address primary-sponsor
    • MHH OE6810
    • Mr.  PD Dr. med.  Oliver  Bachmann 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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  • start of 1:1-Block address primary-sponsor
    • MHH OE5210
    • Mr.  Prof. Dr. med.  Sebastian  Suerbaum 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • MHH OE6810
    • Mr.  PD Dr. med.  Oliver  Bachmann 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address scientific-contact
    • MHH OE5210
    • Mr.  Prof. Dr. med.  Sebastian  Suerbaum 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • MHH OE6810
    • Ms.  BA (FH)  Olesya  Unruh 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Zentrum für Infektionsforschung e. V.
    • Inhoffenstraße 7
    • 38124  Braunschweig
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/06/30
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Trial Publications, Results and other Documents

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