Cohort of the Specialist Network Infectious Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGoethe University
About this trial
This observational study aims to collect standardized clinical data and biosamples from adults in university hospitals across Germany. The main goals are to create a cohort that combines clinical data, pathogen samples, and biosamples, with consent for future research. A pre-screening program tracks infection-related hospitalizations, helping detect pathogen changes early and respond quickly. Participants will be recruited if they have respiratory, bloodstream, gastrointestinal, emerging, or central nervous system infections. Data and biosamples will be collected at the start and end of the hospital stay, with additional visits if needed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fulfillment of all inclusion and no
Disqualifiers
Ability to perform all baseline visit data and biosample collections according to the study requirements no later than 48 hours (with an additional 48-hour period for weekends) after fulfilling all study and specific module inclusion and exclusion criteria
Signed informed consent form from all patients capable of giving consent and understanding all contents of the informed consent
Age ≥ 18 years.
Trial population
Patients with defined clinical characteristics or presentations/pathogens are included at all participating study sites. Specific clinical characteristics or presentations/pathogens of interest are defined in the specific modules. Based on this master study protocol and the modules, the study teams will identify patients who meet all inclusion and none of the exclusion criteria and will inform them about the study and its objectives. Patients providing written IC will be included in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
15,000 Participants
are grouped into 5 trial groupsGroup A: Module Bloodstream Infections
Group B: Module Emerging Infections
Group C: Module Respiratory Infections
Group D: Module Gastrointestinal Infections
Group E: Module CNS Infections
Trial outcomes
Primary outcomes
1
Provision of clinical patient data and biosamples from highly relevant entities of infectious diseases for scientific projects, with no predefined specific outcome, but potentially applicable to various research objectives
As a cohort study with an open research question, various outcomes and factors influencing the disease may be of interest, including disease severity, quality of care, risk, burden, impact on quality of life, and mortality. The sentinel program also enables analysis of the incidence and prevalence of specific pathogens and clinical conditions. The study's primary goal is not to define a specific outcome but to provide data and biosamples for further research. This allows other researchers to conduct their own studies, potentially linking the data with hospital records or integrating health insurance information, thus expanding the analysis scope. Rather than focusing on a single endpoint, the data serve as a foundation for multiple independent analyses. The sentinel program also strengthens research infrastructure by enabling the study of pathogen incidence and clinical conditions.
Time frame
From enrollment to the end of hospital stay (up to 100 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Goethe University
Lead sponsor
German Federal Ministry of Education and Research
Collaborator
Source ClinicalTrials.gov