The Institute of Infectious Diseases and Infection Control (IIMK) conducts its own clinical studies and participates in collaborative studies funded by public funds (e.g. BMBF) or by the pharmaceutical industry.
Applied surveillance and testing
The basis for control and containment in a pandemic is knowledge of infections and transmissions. This requires effective and proportionate testing and surveillance strategies for diverse populations that provide data for early detection of COVID-19 infection chains. In the collaborative project B-FAST a technical platform will be developed together with the Robert Koch Institute (RKI) to collect and network information and knowledge on pandemic events in a structured way, especially in hospitals.
Running time: 01.08.2020-31.12.2021
Funding Institution: BMBF, FKZ 01KX2021
The B-FAST project is a collaborative project with 26 university hospitals and 22 other participating institutions and is carried out within the framework of the National Network of University Hospitals (NUM).
Epidemiology of community-acquired pneumonia in Thuringia
Community Acquired Pneumonia (CAP) is one of the most common infectious diseases worldwide and is associated with high mortality. Nevertheless, there are no valid epidemiological data on incidence and long-term outcomes. The aim of the ThEpiCAP study is to assess the population-based incidence of hospitalized patients with CAP. Within the study, all patients with CAP in hospitals in Jena (UKJ), Gera (SRH Wald-Klinikum Gera) and Suhl (SRH Zentralklinikum Suhl) will be recorded over a period of 24 months. In addition to demographic data, multiplex PCR for pathogen detection from respiratory secretions will be performed, among others. Accurate incidence rates and precise investigations of the underlying pathogen are important to estimate the proportion of disease that would be potentially preventable by vaccination. Epidemiologic data generated from the study can serve as the basis for future vaccine efficacy studies and ultimately lead to evidence-based vaccination recommendations. It is expected that a total of more than 2000 patients will be included in the study.
Running time: 01.12.2019 to 31.12.2023
Funding Institution: Pfizer (USA)
Study of the CoVID-19 outbreak in Neustadt am Rennsteig, Germany
SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2, "Severe Acute Respiratory Syndrome Coronavirus 2") is a coronavirus first identified in 2020 and the causative agent of the currently ongoing pandemic. Symptoms of the disease span the whole spectrum of respiratory diseases. It is now well established that about 85% of symptomatic cases have a mild course and about 15% a severe course. Neustadt am Rennsteig, a community in central Thuringia, experienced an outbreak of SARS-CoV-2 in March and April 2020, prompting the district administration to impose a 14-day quarantine on the whole village. There was a total of 52 diagnosed SARS-CoV-2 infections and three SARS-CoV-2-associated deaths. The exact chains of infection and the origin of the outbreak are unclear. In the CoNAN study, which was conducted from May 2020 to April 2021, we are investigating longitudinally and population-wide the various immunological aspects of the disease (antibody formation, T-cell immunity, formation and progression of neutralizing antibodies, etc.) and collecting epidemiological data on symptom progression. The study is conducted in collaboration with several institutes of the UKJ and will provide further insights into the course of SARS-CoV-2 infections.
Running time: 01.04.2020-30.03.2021
Funding Institution: Free State of Thuringia, FKZ TZUZI82094
Prediction of neonatal sepsis (EONS) after early preterm rupture of membranes by vaginal microbiome analysis
The prospective PEONS pilot study is investigating the impact of the vaginal microbiome on the occurrence of early neonatal sepsis (EONS), defined by the occurrence of confirmed or suspected sepsis within the first 72 hours of life after birth. The study is a multicenter collaboration of the Department of Obstetrics and Neonatology of the University Hospital Jena and the Department of Obstetrics and Prenatal Medicine together with the Department of Neonatology of the University Hospital Halle/S. The entire PEONS study is divided into three work packages: 1. recruitment of patients, sample collection and routine clinical diagnostics, 2. microbiome analysis by 16S rRNA sequencing and 3. microbiome/metagenome analysis by "nanopore sequencing" (proof-of-principle). The Institute of Infectious Diseases and Infection control (IIMK) participates in the PEONS study with microbiome analysis using NanoPore sequencing and the corresponding bioinformatic analysis.
The study is conducted within the Center for Sepsis Control and Care (CSCC).
Competence Network for Community-Acquired Pneumonia
The Institute of Infectious Diseases and Infection Control (IIMK) is affiliated as a local clinical center to the Competence Network for Community-Acquired Pneumonia - CAPNETZ and is in charge of several projects (PROGRESS and SYMP-ARI), within the Competence Network, which deal with epidemiology and diagnostics of community-acquired pneumonia (CAP) and are conducted in collaboration with other members of the CAPNETZ study groups.
Community-acquired pneumonia (CAP) is considered one of the most important infectious diseases worldwide with a high risk of mortality. CAPNETZ is a BMBF-funded network that links practicing and clinically active physicians as well as microbiologists, virologists, epidemiologists and computer scientists in order to significantly improve diagnostics, therapy and patient care. Leading research institutions in Germany cooperate in CAPNETZ. CAPNETZ thus combines clinical, microbiological and basic research aspects in order to gain new insights into disease development, in particular into the interaction between pathogen and host.
Sequential versus simultaneous vaccination with pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPV23) in vaccine-naive older adults: Immunologic memory and antibody levels.
The objective of this prospective, randomized, controlled, monocentric study is to analyze/characterize the humoral immune response after sequential pneumococcal vaccination (PCV13 on day 0 followed by PPV23 6 months later) versus simultaneous pneumococcal vaccination (PCV13 and PPV23 simultaneously on day 0). The immune response of serotype-specific memory B cells will be investigated to determine whether sequential vaccination causes a decline in memory B cells and thus a loss of immunity.
Prospective, randomized, multicenter clinical trial on the impact of therapeutic drug monitoring (TDM) of piperacillin on organ function and survival in patients with severe sepsis or septic shock.
Approved standard antibiotic doses often result in sub-therapeutic levels in ICU patients due to high intra- and inter-individual variability, which studies have associated with treatment failure. TARGET aims to demonstrate for the first time in a prospective, multicenter randomized trial that individualized dosing based on therapeutic drug monitoring can improve the outcome of ICU patients with infections.
The study is conducted within the Center for Sepsis Control and Care (CSCC).
Study of the utility of a statewide counseling program to improve outcomes in patients with Staphylococcus aureus bacteremia - a single-blind, cluster-randomized study in a cross-over design.
The controlled cluster-randomized, multicenter SUPPORT study investigates whether infectious disease consultations by telephone can compensate for the lack of infectious disease specialists in Thuringia and improve survival of patients with Staphylococcus aureus bacteremia (SAB), which is associated with complications in nearly 50% of cases and is lethal in 30%. A total of 21 hospitals from Thuringia participated in the study. Preliminary data show a significant decrease in mortality from SAB due to the consults, from about 23% to 10% and thus by more than half.