Clinical trial NCT06346665: The Transplant Cohort of the German Center for Infection Research
Official title: The Transplant Cohort of the German Center for Infection Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infections
Transplant Complication
Transplant Failure
Immunosuppression
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Hannover Medical School
name: University Hospital Heidelberg
name: Universität Tübingen
name: Klinikum der Universität München
name: Max von Pettenkofer-Institut München
name: Nierenzentrum Heidelberg
name: Helmholtz Centre for Infection Research
First posted: 2024-04-04
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No consent

Primary outcomes:
measure: Realisation of studies that focus on the the medical needs of transplant patients, particularly with regard to their susceptibility to infection
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Technische Universität München
Study officials:
References:
citation: 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.
citation: 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.