Trial document
DRKS00000111
Trial Description
Title
Etiology, Epidemiology and Treatment of Diarrhea and Enterocolitis in Hemato-oncological High Risk Patients (EpiDi)
Trial Acronym
EpiDi
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.
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.
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
- DRKS00000111
- 2009/06/16
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- yes
- Approved
- 09-094, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
Secondary IDs
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Health Condition or Problem studied
- Haematologic malignancy
Interventions/Observational Groups
- No intervention
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
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- Uncontrolled/Single arm
- Supportive care
- Single (group)
- N/A
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Primary Outcome
Incidence of abdominal complications after chemotherapy
Secondary Outcome
Effect of empiric metronidazole or vancomycin on the incidence of abdominal complications
Countries of Recruitment
- Germany
Locations of Recruitment
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Recruitment
- Actual
- 2009/06/03
- 400
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Neutropenia >= 5 days, defined as <500 neutrophils/microL. If no differential blood count available, use <1000 leukocytes/microL
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)
Addresses
-
start of 1:1-Block address primary-sponsor
- Uniklinik Köln
- Kerpener Str. 62
- 50937 Köln
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49 221 478 6494
- +49 221 478 3611
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end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- 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
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 221 478 6494
- +49 221 478 3611
- maria.rueping at ctuc.de
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end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- 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
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 221 478 6494
- +49 221 478 3611
- maria.rueping at ctuc.de
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end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- DFG
- Ms. Christiane Krämer
- 53170 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +49 228/885-1
- +49 228/885-2777
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end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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