Trial document




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  DRKS00000111

Trial Description

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Title

Etiology, Epidemiology and Treatment of Diarrhea and Enterocolitis in Hemato-oncological High Risk Patients (EpiDi)

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Trial Acronym

EpiDi

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In patients with cancer, gastrointestinal infections with certain bacteria are associated with severe complications, such as inflammation of the colon, loss of the barrier function of the colonic wall, generalized infection and death.
Particularly a certain bacterium called Clostridium difficile seems to play a crucial role in this setting. A new strain of this bacterium, called PCR Ribotyp 027 seems to entail complications or death more frequently than previously observed strains.
For this reason, many physicians decide to administer calculated antibiotic therapy with oral metronidazole to patients with abdominal pain or diarrhea after after administration of chemotherapy. There are no results from clinical trials, suporting this strategy. Nevertheless, its practice is recommended by the Arbeitsgemeinschaft Infektionen in der Hämatologie und Onkologie (AGIHO) of the Deutschen Gesellschaft für Hämatologie und Onkologie (DGHO).
Whether patients truely benefit from this treatment can only be assessed in a controlled, randomized clinical trial. At the moment it's not possible to design such a study, because epidemiological data on does not suffice to calculate the number of patients that would be needed to complete such a trial.
In a multicentric observational study, the parameters needed for a reliable case calculation will be documented to assess the feasibility of a clinical trial in this setting.
In a multicentric observational study, the parameters needed for a reliable case calculation will be documented to assess the feasibility of a clinical trial in this setting.

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Brief Summary in Scientific Language

In hemato-oncological high risk patients, abdominal infections with anaerobic bacteria are associated with severe complications, such as enterocolitis, toxic megacolon, perforation, septic shock and death.
Clostridium difficile seems to play a crucial role in this setting. Current reports on the course of abdominal infections with hypervirulent Clostridium difficile PCR Ribotyp 027 strains in Germany and other regions of Europe reported a dramatic rise in morbidity and lethality in association with this pathogen.
For this reason, neutropenic patients with diarrhea and/or other signs of abdominal infection are often provided with an empiric course of oral Metronidazole. Even though this strategy is not supported by evidence from clinical trials, its practice is recommended by the Arbeitsgemeinschaft Infektionen in der Hämatologie und Onkologie (AGIHO) of the Deutschen Gesellschaft für Hämatologie und Onkologie (DGHO).
The clinical efficacy of this strategy can only be assessed in clinical trials. Due to the heterogenicity of prior studies on the epidemiology and course of these infections, a reliable case calculation is currently not possible.
In a multicentric, prospective observational study, the parameters needed for a reliable case calculation will be documented to assess the feasibility of a clinical trial in this setting.

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Organizational Data

  •   DRKS00000111
  •   2009/06/16
  •   [---]*
  •   yes
  •   Approved
  •   09-094, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   Haematologic malignancy
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Interventions/Observational Groups

  •   No intervention
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Characteristics

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

Incidence of abdominal complications after chemotherapy

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Secondary Outcome

Effect of empiric metronidazole or vancomycin on the incidence of abdominal complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/06/03
  •   400
  •   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

Neutropenia >= 5 days, defined as <500 neutrophils/microL. If no differential blood count available, use <1000 leukocytes/microL

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Exclusion Criteria

a) Neutropenia <5 days, defined as <500 neutrophils/microL. If no differential blood count available, use <1000 leukocytes/microL
b) Patients with Colitis ulcerosa, Morbus Crohn or other inflammatory diseases of the colon
c) Patients with diarrhea at admission
d) Patienten, receiving prophylaxis with metronidazole (per os or intravenous) or vancomycin (per os)

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Addresses

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    • Uniklinik Köln
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    •   +49 221 478 6494
    •   +49 221 478 3611
    •   [---]*
    •   [---]*
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    • Uniklinik Köln, Klinik I für Innere Medizin, Studienzentrum 2 für Infektiologie
    • Ms.  Dr. med.  Maria J.G.T.  Rüping 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Uniklinik Köln, Klinik I für Innere Medizin, Studienzentrum 2 für Infektiologie
    • Ms.  Dr. med.  Maria J.G.T.  Rüping 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • DFG
    • Ms.  Christiane  Krämer 
    • 53170  Bonn
    • Germany
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    •   +49 228/885-1
    •   +49 228/885-2777
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    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.