Hematological MalignanciesCoCoNutNCT01821456
Cologne Cohort of Neutropenic Patients (CoCoNut)
An observational study of Hematological Malignancies and Cancer, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Hematological Malignancies, Cancer, Chemotherapy
- What is being tested?
- Antiinfectives
- How many people
- 100,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 1995to Dec 2050
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients developing neutropenia after receiving chemotherapy for any kind of malignant disease, treated in the University Hospital of Cologne
Who may be able to join
- immunosuppressed patients
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50924
Jörg Janne Vehreschild, Dr. med., +0049 (0)221 478-6494 ext. -6494, janne.vehreschild@ctuc.de
Oliver Andreas Cornely, Prof. Dr. med., 0049 (0)221 478-6494 ext. -6494, oliver.cornely@ctuc.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Hematological Malignancies, Cancer, Chemotherapy, Neutropenia, Immunosuppression
- Being tested
- Antiinfectives
- Keywords
- hematological malignancies, cancer, chemotherapy, anti-infectives, treatment, outcome
- Medical subject headings
- Hematologic Neoplasms, Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntiinfectivesDrug
Also called Antifungals, Antibacterials, Antivirals
To analyze to efficacy of (novel) drug therapies
| Study group | Role | What they receive |
|---|---|---|
| Antiinfectives | To analyze the efficacy of antiinfectives at high risk patients Receives: Drug: Antiinfectives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term survival of hematology and oncology patients following neutropenia
Measured: 2 years following last follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startJan 1995
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821456
- Sponsor's protocol ID
- !SZINF2
- Other IDs
- !!SZINF2
- Acronym
- CoCoNut
- Status last verified
- Mar 2013
- First submitted
- 19 Mar 2013
- Last updated
- 1 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 20410061Vehreschild 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.
PubMed 24798021Vehreschild 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.
PubMed 24607558