- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01821456
Cologne Cohort of Neutropenic Patients (CoCoNut) (CoCoNut)
March 26, 2013 updated by: University Hospital of Cologne
The Cologne Cohort of Neutropenic Patients (CoCoNut) - a Non-interventional Cohort Study Assessing Risk Factors, Interventions, and Outcome of Immunosuppressed Patients With or Without Opportunistic Infections
The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study assessing risk factors, interventions, and outcome of immunosuppressed patients with or without opportunistic infections.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
This prospective cohort was established with the aim of a comprehensive data collection of all patients developing neutropenia after receiving chemotherapy for any kind of malignant disease, treated in the University Hospital of Cologne.
Study Type
Observational
Enrollment (Anticipated)
100000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, Germany, 50924
- Recruiting
- University Hospital of Cologne
-
Contact:
- Jörg Janne Vehreschild, Dr. med.
- Phone Number: -6494 +0049 (0)221 478-6494
- Email: janne.vehreschild@ctuc.de
-
Contact:
- Oliver Andreas Cornely, Prof. Dr. med.
- Phone Number: -6494 0049 (0)221 478-6494
- Email: oliver.cornely@ctuc.de
-
Principal Investigator:
- Jörg J. Vehreschild, Dr. med.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients developing neutropenia after receiving chemotherapy for any kind of malignant disease, treated in the University Hospital of Cologne
Description
Inclusion Criteria:
- immunosuppressed patients
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Antiinfectives
To analyze the efficacy of antiinfectives at high risk patients
|
To analyze to efficacy of (novel) drug therapies
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Long-term survival of hematology and oncology patients following neutropenia
Time Frame: 2 years following last follow-up
|
2 years following last follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Vehreschild JJ, Ruping MJ, Wisplinghoff H, Farowski F, Steinbach A, Sims R, Stollorz A, Kreuzer KA, Hallek M, Bangard C, Cornely OA. Clinical effectiveness of posaconazole prophylaxis in patients with acute myelogenous leukaemia (AML): a 6 year experience of the Cologne AML cohort. J Antimicrob Chemother. 2010 Jul;65(7):1466-71. doi: 10.1093/jac/dkq121. Epub 2010 Apr 21.
- Vehreschild MJ, von Bergwelt-Baildon M, Tran L, Shimabukuro-Vornhagen A, Wisplinghoff H, Bangard C, Cornely OA, Vehreschild JJ. Feasibility and effectiveness of posaconazole prophylaxis in combination with micafungin bridging for patients undergoing allogeneic stem cell transplantation: a 6-yr analysis from the cologne cohort for neutropenic patients. Eur J Haematol. 2014 Nov;93(5):400-6. doi: 10.1111/ejh.12368. Epub 2014 May 26.
- Vehreschild MJ, Weitershagen D, Biehl LM, Tacke D, Waldschmidt D, Tox U, Wisplinghoff H, Von Bergwelt-Baildon M, Cornely OA, Vehreschild JJ. Clostridium difficile infection in patients with acute myelogenous leukemia and in patients undergoing allogeneic stem cell transplantation: epidemiology and risk factor analysis. Biol Blood Marrow Transplant. 2014 Jun;20(6):823-8. doi: 10.1016/j.bbmt.2014.02.022. Epub 2014 Mar 6.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1995
Primary Completion (Anticipated)
December 1, 2050
Study Completion (Anticipated)
December 1, 2050
Study Registration Dates
First Submitted
March 19, 2013
First Submitted That Met QC Criteria
March 26, 2013
First Posted (Estimate)
April 1, 2013
Study Record Updates
Last Update Posted (Estimate)
April 1, 2013
Last Update Submitted That Met QC Criteria
March 26, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- !SZINF2
- !!SZINF2 (Other Identifier: University Hospital of Cologne)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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