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RecruitingNCT06346665Updated Apr 23, 2024

The Transplant Cohort of the German Center for Infection Research

An observational study in Infections, Transplant Complication and Transplant Failure, sponsored by Technical University of Munich. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by Technical University of Munich · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2016; still recruiting 10 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Sex
All
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Study 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 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.

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Conditions studied

  • Infections
  • Transplant Complication
  • Transplant Failure
  • Immunosuppression
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In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Inclusion criteria

  • Consent
  • undergone transplantation of kidney, pancreas, liver, heart or stem cells

Exclusion criteria

Exclusion Criteria:

  • No consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 years

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Study locations

1 of 1 sites recruiting
  • Technische Universität München
    München, Germany
    • Daniela Schindle, Dr. · Contact
    Recruiting
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References and documents

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 33492549 ↗
  • Sommerer 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 ↗

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Icf

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06346665
Lead sponsor
Technical University of Munich
Collaborators
Hannover Medical School, University Hospital Heidelberg, Universität Tübingen, Klinikum der Universität München, Max von Pettenkofer-Institut München, Nierenzentrum Heidelberg, Helmholtz Centre for Infection Research
Responsible party
Sponsor
First posted
Apr 4, 2024
Start date
Jan 2016
Primary completion
Dec 2025 (estimated)
Completion
Dec 2030 (estimated)
Last update
Apr 23, 2024

Study contacts

Daniela Schindler, Dr.
Contact
daniela.schindler@tum.de

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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