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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01821456
- Acronym / sponsor ID
- CoCoNut / !SZINF2
- Conditions
- Hematological Malignancies, Cancer, Chemotherapy, Neutropenia, Immunosuppression
- Keywords
- hematological malignancies, cancer, chemotherapy, anti-infectives, treatment, outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- Jan 1995
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 1 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antiinfectives | – | Drug: AntiinfectivesTo analyze the efficacy of antiinfectives at high risk patients |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- immunosuppressed patients
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntiinfectivesAlso: Antifungals, Antibacterials, AntiviralsTo analyze to efficacy of (novel) drug therapies | Drug | Antiinfectives |
Primary outcome
Long-term survival of hematology and oncology patients following neutropenia
Time frame: 2 years following last follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2013.
- Results publication: PubMed 20410061Vehreschild 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.
- Derived from this study: PubMed 24798021Vehreschild 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.
- Derived from this study: PubMed 24607558Vehreschild 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancies and Cancer, run by University Hospital of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term survival of hematology and oncology patients following neutropenia (time frame: 2 years following last follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01821456, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2013.