InfectionsNCT06346665
The Transplant Cohort of the German Center for Infection Research
An observational study of Infections and Transplant Complication, run by Technical University of Munich at 1 site in Germany.
Trial summary
Medical data and biological samples obtained from transplant patients are collected and managed across Germany with the help of the DZIF Transplant Cohort. The data and samples form the basis of scientific studies which investigate the connections between numerous factors influencing an organ's susceptibility to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infections, Transplant Complication, Transplant Failure
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Dec 2030
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of any age who have received a kidney, pancreas, liver, heart or stem cell transplant at one of the listed partner centres
Who may be able to join
- Consent
- undergone transplantation of kidney, pancreas, liver, heart or stem cells
Who cannot join
- No consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Daniela Schindler, Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Technische Universität München
München
Daniela Schindle, Dr.
About this study
Medical data and biological samples obtained from transplant patients are collected and managed across Germany with the help of the DZIF Transplant Cohort. The data and samples form the basis of scientific studies which investigate the connections between numerous factors influencing an organ's susceptibility to infection and organ function.
Read the detailed description
Infections in transplant recipients have a decisive impact on graft function and survival of the transplant recipient, but many issues are still poorly understood. For example, little is known about the long-term consequences of many infections on graft survival/function and graft- versus-host disease (GvHD), the role of individual susceptibility to bacterial, viral and fungal colonisation under immune suppression, the evolution of the antiviral T cell repertoire, the long- term impact of antiviral therapy on graft and patient survival or changes in the physiological microbiome that may have a bearing on colonisation with pathogenic microbes. Taking advantage of the fact that most of the university hospitals with sizeable transplantation programs in Germany are also DZIF partners, we will establish a large multicentre prospective observational cohort of transplant recipients.
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Realisation of studies that focus on the the medical needs of transplant patients, particularly with regard to their susceptibility to infection
Provision of collected data and biosamples to research groups for the realisation of scientific studies with a number of resources that individual clinics could not provide on their own
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study startJan 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School, University Hospital Heidelberg, Universität Tübingen, LMU Klinikum, Max von Pettenkofer-Institut München, Nierenzentrum Heidelberg, Helmholtz Centre for Infection Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346665
- Sponsor's protocol ID
- DZIF Tx-Cohort
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The use of collected data and biosamples is possible on the basis of an application to the Scientific Steering Committee of the transplant cohort. Cooperations with members of the cohort are welcome
Publications
Karch A, Schindler D, Kuhn-Steven A, Blaser R, Kuhn KA, Sandmann L, Sommerer C, Guba M, Heemann U, Strohaker J, Glockner S, Mikolajczyk R, Busch DH, Schulz TF; for the Transplant Cohort of the German Center for Infection Research (DZIF Transplant Cohort) Consortium. The transplant cohort of the German center for infection research (DZIF Tx-Cohort): study design and baseline characteristics. Eur J Epidemiol. 2021 Feb;36(2):233-241. doi: 10.1007/s10654-020-00715-3. Epub 2021 Jan 25.
PubMed 33492549Sommerer C, Schroter I, Gruneberg K, Schindler D, Behnisch R, Morath C, Renders L, Heemann U, Schnitzler P, Melk A, Della Penna A, Nadalin S, Heeg K, Meuer S, Zeier M, Giese T; Transplant Cohort of the German Center for Infection Research (DZIF Transplant Cohort) Consortium. Incidences of Infectious Events in a Renal Transplant Cohort of the German Center of Infectious Diseases (DZIF). Open Forum Infect Dis. 2022 May 13;9(7):ofac243. doi: 10.1093/ofid/ofac243. eCollection 2022 Jul.
PubMed 35855001
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Transplant Cohort of the German Center for Infection Research
- ClinicalTrials.gov ID
- NCT06346665
- Acronym / sponsor ID
- DZIF Tx-Cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Hannover Medical School, University Hospital Heidelberg, Universität Tübingen, LMU Klinikum, Max von Pettenkofer-Institut München, Nierenzentrum Heidelberg, Helmholtz Centre for Infection Research
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Apr 2024 (actual)
- 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.
Medical data and biological samples obtained from transplant patients are collected and managed across Germany with the help of the DZIF Transplant Cohort. The data and samples form the basis of scientific studies which investigate the connections between numerous factors influencing an organ's susceptibility to infection and organ function.
Detailed description
Infections in transplant recipients have a decisive impact on graft function and survival of the transplant recipient, but many issues are still poorly understood. For example, little is known about the long-term consequences of many infections on graft survival/function and graft- versus-host disease (GvHD), the role of individual susceptibility to bacterial, viral and fungal colonisation under immune suppression, the evolution of the antiviral T cell repertoire, the long- term impact of antiviral therapy on graft and patient survival or changes in the physiological microbiome that may have a bearing on colonisation with pathogenic microbes. Taking advantage of the fact that most of the university hospitals with sizeable transplantation programs in Germany are also DZIF partners, we will establish a large multicentre prospective observational cohort of transplant recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of any age who have received a kidney, pancreas, liver, heart or stem cell transplant at one of the listed partner centres
Key inclusion criteria (2 listed)
- Consent
- undergone transplantation of kidney, pancreas, liver, heart or stem cells
Key exclusion criteria (1 listed)
- No consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Realisation of studies that focus on the the medical needs of transplant patients, particularly with regard to their susceptibility to infection
Time frame: 10 years
Provision of collected data and biosamples to research groups for the realisation of scientific studies with a number of resources that individual clinics could not provide on their own
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 23 Apr 2024.
- Results publication: PubMed 33492549Karch A, Schindler D, Kuhn-Steven A, Blaser R, Kuhn KA, Sandmann L, Sommerer C, Guba M, Heemann U, Strohaker J, Glockner S, Mikolajczyk R, Busch DH, Schulz TF; for the Transplant Cohort of the German Center for Infection Research (DZIF Transplant Cohort) Consortium. The transplant cohort of the German center for infection research (DZIF Tx-Cohort): study design and baseline characteristics. Eur J Epidemiol. 2021 Feb;36(2):233-241. doi: 10.1007/s10654-020-00715-3. Epub 2021 Jan 25.
- Results publication: PubMed 35855001Sommerer C, Schroter I, Gruneberg K, Schindler D, Behnisch R, Morath C, Renders L, Heemann U, Schnitzler P, Melk A, Della Penna A, Nadalin S, Heeg K, Meuer S, Zeier M, Giese T; Transplant Cohort of the German Center for Infection Research (DZIF Transplant Cohort) Consortium. Incidences of Infectious Events in a Renal Transplant Cohort of the German Center of Infectious Diseases (DZIF). Open Forum Infect Dis. 2022 May 13;9(7):ofac243. doi: 10.1093/ofid/ofac243. eCollection 2022 Jul.
- Transplant Cohort Website of the DZIFLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The use of collected data and biosamples is possible on the basis of an application to the Scientific Steering Committee of the transplant cohort. Cooperations with members of the cohort are welcome
Related trials for Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
Daniela Schindler, Dr. contact
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 Infections and Transplant Complication, run by Technical University of Munich 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 2 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 23 Apr 2024. 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?
Contact Daniela Schindler, Dr. (daniela.schindler@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Realisation of studies that focus on the the medical needs of transplant patients, particularly with regard to their susceptibility to infection (time frame: 10 years). 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 NCT06346665, which also lists 2 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 23 Apr 2024.