The Transplant Cohort of the German Center for Infection Research

April 22, 2024 updated by: Technical University of Munich
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • München, Germany
        • Recruiting
        • Technische Universität München
        • Contact:
          • Daniela Schindle, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

Hannover Medical School
University Hospital Heidelberg
Klinikum der Universität München
Universität Tübingen
Helmholtz Centre for Infection Research
Max von Pettenkofer-Institut München
Nierenzentrum Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DZIF Tx-Cohort

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

The use of resources is possible after successful review of the preliminary and main application to the transplant cohort by the internal Scientific Steering Committee and - depending on the study design - external reviewers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infections

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe