An observational study in Infectious Diseases and Manifestations, sponsored by Goethe University. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Goethe University · Observational
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Among 17 studies in Communicable Diseases with a site in Germany — 5 open to participants now, 7 under way, none of them phase 3. Communicable Diseases · Germany.
Among the 17 studies in Communicable Diseases with a site in Germany, this one is the 2nd largest by planned enrollment of the 10 observational ones that give a count, is one of 2 that started in 2025, is one of 10 observational ones, and was the 16th registered.
627 studies on the registry are indexed under Communicable Diseases; 129 are open to participants now.
Browse Communicable Diseases studies →5 of the 17 studies in Communicable Diseases with a site in Germany are open now. Recruiting first, the newest first:
University of Minnesota · Sites in Germany, United States, Argentina and 18 more countries
Ages 18+
CytoSorbents, Inc · Sites in Germany, Austria, Italy and 3 more countries
Technical University of Munich · Sites in Germany
Ages 18+ · Healthy volunteers
Erasmus Medical Center · Sites in Germany, United States, Denmark and 3 more countries
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 92 Communicable Diseases studies recruiting now, 49 (53%) set no upper age limit and 32 (35%) stop at 75 or younger; 36 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 15,000 is above the median of 200 across 229 observational studies indexed under Communicable Diseases.
Median enrollment 139 across the 7 interventional studies, 705 across the 10 observational. Of the 9 that completed or were terminated, 2 (22%) have results posted.
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5 of 17 have an industry lead sponsor. The 10 most frequent:
Goethe University is the lead sponsor of 98 studies on the registry; 15 are open to participants now.
Goethe University has 1 study filed under Communicable Diseases — fewer than ten, so there is no comparison to draw.
1 of the studies in Communicable Diseases with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07069400University of MinnesotaAn International Observational Study of Adults With Acute Infection | 2027-06-08 |
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Among the 17 studies in Communicable Diseases with a site in Germany, from their registry updates:
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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.
As part of the European concept of ever-warm recruiting infrastructures in case of future public health hazards, but also as instrument for answering pressing questions in the field of major infectious diseases, the cohort of the Specialist Network Infectious Diseases (SNID) collects clinical patient data and biosamples in a standardized and quality-assured manner. In this sense, the SNID manifests itself as a structured data and decentralized biobank within the German Network University Medicine (NUM).
The main objectives of the SNID cohort are: 1) To collect clinical patient data and biosamples from major infectious diseases to accelerate translational and outcomes research with the aim of improving diagnosis and treatment strategies for future patients, 2) To establish pandemic preparedness by initiating and maintaining an ever-warm recruitment network in the field of infectious diseases, 3) To establish a sentinel programme to observe and monitor outbreaks of severe infections requiring hospitalization of patients.
The study will identify and recruit patients across different specific modules, each providing a sub-protocol to this master study protocol. These modules focus on major areas of infectious diseases ("entities") and will describe research questions and priorities as well as specific requirements for the observation of the respective affected patients. They will also denominate specific sub-types ("sub-entities") of these diseases that are or may become a focus of the SNID cohort. As an example, the module "respiratory infections" may have an entity "community-acquired pneumonia" that in turn may have sub-entities like "community-acquired pneumonia caused by legionella pneumophila".
A base of sociodemographic, epidemiologic, and clinical patient data is documented, including information on possible pre-existing conditions, medical diagnoses, and therapies.
The documentation is supplemented by residual or non-invasive biosampling, depending on the study tier. Three different tiers establish different levels of sampling and data collection in terms of frequency or depth of assessment. The Tiers have been adapted mainly from the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC).
Tier 2: Serial collection of data and biosamples (additional non-invasive collection of biosamples and residual samples) at the baseline visit, once a week starting on day 3 until the final visit (corresponding to tier 2, sampling schedule 4 by ISARIC).
Tier 1: Collection of data and biosamples (additional non-invasive collection of biosamples and residual samples) at baseline visit and final visit (corresponding to tier 1 by ISARIC).
Tier 0: Only documentation of data and preservation of residual samples (routine clinical care) at baseline visit and final visit (corresponding to tier 0 by ISARIC).
For tier 1 and 2, additional non-invasive biosamples may be collected as part of the study. Non-invasive is defined as no new tissue penetration or other harm to the patient, allowing for swabbing, collection of spontaneously ejectable fluids/substances, or usage of permanent devices or non-invasive access to materials.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
There are no generic exclusion criteria in the master study protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This sub-cohort focuses on the characterization of patients with both nosocomial and community-acquired bloodstream infections (BSI), serving as a foundation for future prospective randomized controlled clinical trials. The study will explore the evolution of BSI caused by multidrug-resistant or emerging pathogens and assess the prognosis and long-term outcomes of patients with BSI in Germany. Additionally, the cohort will evaluate patient- and pathogen-related risk factors associated with BSI.
The sub-cohort includes identifying and monitoring emerging pathogens to stay ahead of potential health threats, as well as developing a targeted screening program to detect infections caused by established pathogens like Mpox and Candida auris. The sub-cohort will also expand detection efforts to include pathogens not yet established in Germany, such as dengue virus, particularly in regions where this is not yet addressed by other modules. Additionally, the study team will perform an extended risk and exposure assessment for participating patients according to a defined protocol.
The sub-cohort includes the creation of a searchable data and biosample repository for community-acquired respiratory tract infections (CARTI), not limited to pneumonia, enabling research on pathogens, clinical presentations, treatments, and patient outcomes. The biosamples will support future studies on pathogen identification, immune responses, and therapeutic efficacy. It will also document a range of pathogens, including emerging ones, and their frequencies across various CARTI, allowing analysis of associations with factors like age, gender, and comorbidities. Therapeutic data will track primary anti-infective treatments and adjustments based on resistogram results or clinical needs to assess their impact on outcomes. Key clinical outcomes, such as hospital mortality, length of stay, and complications, will be tracked to explore the effects of pathogen type, comorbidities, and treatments on patient outcomes.
The sub-cohort enrolls patients with bacterial, viral, and parasitic gastrointestinal (GI) infections identified through routine diagnostics, including those from hematology units screened for GI colonization with multidrug-resistant pathogens like MRGN or Vancomycin-resistant enterococci (VRE). A key focus is comparing GI pathogen translocation into the bloodstream with the bloodstream infection module, identifying risk factors and transmission routes. The study also assesses antimicrobial resistance (AMR) in enteric pathogens and colonizing enterobacteria, while systematically biobanking stool samples for resistance analysis and pathogen characterization, such as hypervirulent Clostridioides difficile ribotypes or Giardia intestinalis resistance mechanisms. Outcome data collection includes complex Salmonella infections and rare parasitic infections like Cryptosporidium parvum.
The sub-cohort focuses on Central Nervous System (CNS) infections, which are a major public health concern due to their potential to cause severe neurological damage and high mortality. The goal of this project is to create a searchable dataset derived from routine clinical data and biobanked biosamples, which will facilitate future research into CNS infections. The dataset will support studies on pathogen profiles, diagnostic pathways, and clinical outcomes, helping to understand the underlying mechanisms of CNS infections. Additionally, the project aims to explore prognostic markers, treatment responses, and outcomes, with the goal of improving risk stratification and informing personalized treatment strategies for CNS infections.
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)
Started May 2025 (actual). Primary completion is estimated for Jun 2030, 61 months after the start.
Of 128 non-industry observational studies under Communicable Diseases, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 77. This study's planned 61 months is above that.
Counting every sponsor, half of 142 studies reached it within 37 months; a quarter within 17 and three quarters within 94.
Start moved once since we started tracking on Sep 25, 2026: Mar 2025 → May 2025, on Sep 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Goethe University