Clinical Trials
Clinical Trial Unit
Study Nurses
Magda Zanella
Yuliia Vasylkevych
Sonja Friese
Nicole Tewes
Flow Cytometry Core Operator
Dr. Nelli Baal
Data Management
Olga Dakischew
Clinician Team
PD Dr. med. Ulrich Matt, PhD
Dr. med. Janina Trauth
Dr. med. Vera Kantelhardt
Dr. med. Ulla Maria Albrecht
Dr. med. Joscha Schork
Christina Malainou, MD, PhD
Julian Better, MD, PhD
Dr. med. Johanna Kohlhaas
In collaboration with the Volkswagen Foundation
Swarm Learning for precision medicine in infectious diseases and pandemic preparedness
The growing availability of extensive medical data, particularly high-resolution (single-cell) multi-omics data, underscores the importance of integrating machine learning and artificial intelligence (ML/AI) in advancing data-driven precision medicine. Significant challenges, however, persist for instance in utilizing single-cell patient data across diverse clinical settings, addressing data protection and privacy concerns, ensuring generalizability and reliability of ML/AI applications, and navigating ethical implications. A collaborative interdisciplinary team of experts aims to tackle these issues within the context of infectious diseases and pandemic preparedness by utilizing the Swarm Learning principle.
In collaboration with the Network University Medicine NUM
NUM STUDY NETWORK (NUM SN)
NUM Study Network (NUM SN) aims to develop an effective system of cooperation in the field of clinical and clinical-epidemiological studies in Germany.
Specialist Network Infectious Diseases (SNID)
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 SNID cohort 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).
COVIM
COVIM (COllaboratiVe IMmunity Platform of the NUM) is a nationwide network of leading scientists and clinicians from the fields of immunology, virology, clinical infectious diseases, epidemiology, and data science.
In collaboration with the DZL
GI-COVID
Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to prevent ARDS in COVID-19 pneumonia
The scope of this trial is to improve host defense of the lung and at the same time drive repair of the injured organ in hospitalized patients with COVID-19 pneumonia by inhalation of granulocyte-macrophage colony stimulating factor (GM-CSF; Molgramostim), a cytokine that has been shown to exert both of these effects in the lung. This study is funded by the BMBF as part of the “Nationales Forschungsnetz zoonotische Infektionskrankheiten”
GI-Hope
Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) Inhalation to Improve Host Defense and Pulmonary Barrier Restoration
This trial evaluates efficacy and safety of inhaled molgramostim (rhGM-CSF) in 45 patients with community-associated pneumonia (CAP)-related acute respiratory distress syndrome (ARDS).
A third of the patients will receive 150 mcg inhaled molgramostim, another third 450 mcg and the remaining third will receive inhaled placebo for 3 days. The patients will be followed for 28 days.
clinicaltrials.gov →
In collaboration with the German Center for Infection Research DZIF
R-Net
R-Net investigates the effect of various interventions aimed at limiting the spread of infections due to multi-drug resistant organisms (MDRO) – including infection prevention and control, decolonization, antimicrobial stewardship (AMS) and the development of new antimicrobials active against MDRO. Key epidemiological, microbiological, and clinical background data on multi-drug resistant pathogens will be collected over a period of four years at six DZIF partner sites.
As participating site
Infectious disease area: Hepatitis D
Bulevirtide (GS-US-589-6206)
A registry study of treatment with Bulevirtide in participants with Chronic Hepatitis D infection, with the aim of collecting post marketing data from patients with chronic hepatitis D virus infection undergoing treatment with bulevirtide, in order to describe the long-term effects of the treatment and to assess the safety of participants undergoing treatment. clinicaltrials.gov →
Infectious disease area: Candidemia and/or Invasive Candidiasis
FMGX
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida.
Infectious disease area: Clostridium difficile
BODEGA
A multicenter observational post-authorization cohort study with the goal of assessing the clinical efficacy of Bezlotoxumab for the prevention of recurrent Clostridium difficile infections within the German health care system. pei.de →
Infectious disease area: Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Network Adaptive Platform Trial (SNAP)
The Staphylococcus aureus Network Adaptive Platform (SNAP) trial is an International Multi-Centered Randomised Adaptive Platform Clinical Trial to evaluate a range of interventions to reduce mortality for patients with Staphylococcus Aureus bacteraemia (SAB).
Infectious Disease Area: Pneumonia
AON-D21
An Exploratory, Multi-Centre, Interventional, Prospective, Randomised, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of AON-D21 in Patients with Severe Community-Acquired Pneumonia. aptarion.com →
Epidemiological Study on Community Acquired Pneumonia (CAP)
Long-term objectives of the basic research part are improvement of CAP-management with respect to therapy, diagnosis and prevention to contribute to a better care of patients with pneumonia. The aim of the study CAPNETZ is to improve diagnosis, treatment and patient care.
Infectious Disease Area: Tuberculosis
MDR TB
Germany is a low-incidence country when it comes to tuberculosis. However, the relatively high number of treatment discontinuations among patients with tuberculosis indicates low treatment adherence and an unsatisfactory care structure. No1Lost, an extensive collaborative project funded by the Federal Ministry of Health (BMG), aims to specifically improve care – through the development of a “therapy adherence competence network” and research into relevant risk factors.
Infectious disease area: HIV
LAPTOP
An open-label, multicenter, randomized study that aims to explore the effectiveness of integrase inhibitor in comparison to boosted protease inhibitor antiretroviral therapy for patients with advanced HIV disease. neat-id.org/laptop →
HIV-1 Seroconverter Study
A prospective, multicenter, nationwide long-term observational study in Germany that aims to investigate, amongst others, the influence of host and viral factors as well as resistance mutations to antiretroviral therapy on the course of HIV infection, long-term effects of antiretroviral therapy on the course of the infection and the incidence of comorbidities, influence of co-infections on the course of the infection, and SARS-CoV-2 infection in people with HIV. rki.de →
German HIV Pregnancy Registry
Systematic collection and analysis of data on pregnancies of HIV-positive women and the outcome of their children to allow for regular scientific evaluation of the German data. daignet.de →