The Transplant Cohort of the German Center for Infection Research

Infections Clinical Trial

Official title:

The Transplant Cohort of the German Center for Infection Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06346665
• Other study ID #: DZIF Tx-Cohort
• Status: Recruiting
• Start date: January 2016
• Est. completion date: December 2030

Study information

• Verified date: March 2024
• Source: Technical University of Munich
• Contact: Daniela Schindler, Dr.
• Email: daniela.schindler[@]tum.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 infection and organ function.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No consent

Related Conditions & MeSH terms

• Communicable Diseases
• Immunosuppression
• Infections
• Transplant Failure

Locations

Country	Name	City	State
Germany	Technische Universität München	München

Sponsors (8)

Lead Sponsor	Collaborator
Technical University of Munich	Hannover Medical School, Helmholtz Centre for Infection Research, Klinikum der Universität München, Max von Pettenkofer-Institut München, Nierenzentrum Heidelberg, Universität Tübingen, University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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) — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 years

External Links

•   Transplant Cohort Website of the DZIF