9 results on '"Steinbach, Angela"'
Search Results
2. VACCELERATE Site Network: Real-time definition of clinical study capacity in Europe
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Salmanton-García, Jon, Wipfler, Pauline, Valle-Simón, Paula, Merakou, Christina, Kopsidas, Ioannis, Bethe, Ullrich, Steinbach, Angela, Spivak, Orly, Součková, Lenka, Mendonça, Maria Amélia, Koniordou, Markela, Hellemans, Margot, Frías-Iniesta, Jesus, Davis, Ruth Joanna, Barta, Imre, Azzini, Anna Maria, Askling, Helena H, Argyropoulos, Christos D, Álvarez-Barco, Elena, Akova, Murat, Bonten, Marc M J, Cohen-Kandli, Miriam, Cox, Rebecca Jane, Flisiak, Robert, Husa, Petr, Jancoriene, Ligita, Koscalova, Alena, Launay, Odile, Lundgren, Jens, Mallon, Patrick, Marques, Laura, Nauclér, Pontus, Ochando, Jordi, Pana, Zoi-Dorothea, Tacconelli, Evelina, Tóth, Krisztina, Trelle, Sven, van Damme, Pierre, Zaoutis, Theoklis E, Zeitlinger, Markus, Albus, Kerstin, Stewart, Fiona A, Hofstraat, Sanne H I, Bruijning-Verhagen, Patricia, Cornely, Oliver A, VACCELERATE consortium, Unión Europea. Comisión Europea. H2020, and Federal Ministry of Education & Research (Alemania)
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Registry ,Infectious Diseases ,General Veterinary ,General Immunology and Microbiology ,SARS-CoV-2 ,Public Health, Environmental and Occupational Health ,Vaccine trial ,Molecular Medicine ,Clinical network ,Pandemic preparedness ,Site - Abstract
Background: The inconsistent European vaccine trial landscape rendered the continent of limited interest for vaccine developers. The VACCELERATE consortium created a network of capable clinical trial sites throughout Europe. VACCELERATE identifies and provides access to state-of-the-art vaccine trial sites to accelerate clinical development of vaccines. Methods: Login details for the VACCELERATE Site Network (vaccelerate.eu/site-network/) questionnaire can be obtained after sending an email to. Interested sites provide basic information, such as contact details, affiliation with infectious disease networks, main area of expertise, previous vaccine trial experience, site infrastructure and preferred vaccine trial settings. In addition, sites can recommend other clinical researchers for registration in the network. If directly requested by a sponsor or sponsor representative, the VACCELERATE Site Network pre-selects vaccine trial sites and shares basic study characteristics provided by the sponsor. Interested sites provide feedback with short surveys and feasibility questionnaires developed by VACCELERATE and are connected with the sponsor to initiate the site selection process. Results: As of April 2023, 481 sites from 39 European countries have registered in the VACCELERATE Site Network. Of these, 137 (28.5 %) sites have previous experience conducting phase I trials, 259 (53.8 %) with phase II, 340 (70.7 %) with phase III, and 205 (42.6 %) with phase IV trials, respectively. Infectious diseases were reported as main area of expertise by 274 sites (57.0 %), followed by any kind of immunosuppression by 141 (29.3 %) sites. Numbers are super additive as sites may report clinical trial experience in several indications. Two hundred and thirty-one (47.0 %) sites have the expertise and capacity to enrol paediatric populations and 391 (79.6 %) adult populations. Since its launch in October 2020, the VACCELERATE Site Network has been used 21 times for academic and industry trials, mostly interventional studies, focusing on different pathogens such as fungi, monkeypox virus, Orthomyxoviridae/influenza viruses, SARS-CoV-2, or Streptococcus pneumoniae/pneumococcus. Conclusions: The VACCELERATE Site Network enables a constantly updated Europe-wide mapping of experienced clinical sites interested in executing vaccine trials. The network is already in use as a rapid-turnaround single contact point for the identification of vaccine trials sites in Europe. The VACCELERATE Site Network has received funding from the European Union’s Horizon 2020 research and innovation pro gramme (grant agreement No 101037867) and the German Federal Ministry of Education and Research (Bundesministerium für Bil dung und Forschung [BMBF]) (grant agreement No BMBF01KX2040). Sí
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- 2023
3. VACCELERATE Volunteer Registry: A European study participant database to facilitate clinical trial enrolment
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Salmanton-García, Jon, Stewart, Fiona A, Heringer, Sarah, Koniordou, Markela, Álvarez-Barco, Elena, Argyropoulos, Christos D, Themistocleous, Sophia C, Valle-Simón, Paula, Spivak, Orly, Součková, Lenka, Merakou, Christina, Amélia Mendonça, Maria, Joanna Davis, Ruth, Maria Azzini, Anna, Askling, Helena H, Vene, Sirkka, Van Damme, Pierre, Steinbach, Angela, Shiamakkides, George, Seidel, Danila, Olesen, Ole F, Noula, Evgenia, Macken, Alan, Luís, Catarina, Leckler, Janina, Launay, Odile, Isitt, Catherine, Hellemans, Margot, Frías-Iniesta, Jesús, Di Marzo, Romina, Carcas, Antonio J, Boustras, George, Borobia, Alberto M, Barta, Imre, Albus, Kerstin, Akova, Murat, Ochando, Jordi, Cohen-Kandli, Miriam, Jane Cox, Rebecca, Husa, Petr, Jancoriene, Ligita, Mallon, Patrick, Marques, Laura, Mellinghoff, Sibylle C, Nauclér, Pontus, Tacconelli, Evelina, Tóth, Krisztina, Zaoutis, Theoklis E, Zeitlinger, Markus, Cornely, Oliver A, Pana, Zoi-Dorothea, VACCELERATE consortium, Federal Ministry of Education & Research (Alemania), Unión Europea. Comisión Europea. H2020, and VACCELERATE Consortium
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Vaccination campaign ,Adult ,Volunteers ,History ,COVID-19 ,Clinical trial ,Pandemic preparedness ,Registry ,SARS-CoV-2 ,Vaccination network ,Volunteer ,Polymers and Plastics ,Industrial and Manufacturing Engineering ,Humans ,Registries ,Business and International Management ,Child ,registry ,pandemic preparedness ,clinical trial ,volunteer ,vaccination campaign ,vaccination network ,Clinical Trials as Topic ,General Veterinary ,General Immunology and Microbiology ,Public Health, Environmental and Occupational Health ,Europe ,Infectious Diseases ,Molecular Medicine ,Human medicine ,Patient Participation - Abstract
Introduction: The coronavirus disease 2019 (COVID-19) pandemic has evidenced the key role of vaccine design, obtention, production and administration to successfully fight against infectious diseases and to provide efficient remedies for the citizens. Although clinical trials were rapidly established during this pandemic, identifying suitable study subjects can be challenging. For this reason, the University Hospital Cologne established a volunteer registry for participation in clinical trials first in Germany, which has now been incorporated into the European VACCELERATE clinical trials network and grew to a European Volunteer Registry. As such, VACCELERATE's Volunteer Registry aims to become a common entry point for potential volunteers in future clinical trials in Europe. Methods: Interested volunteers who would like to register for clinical trials in the VACCELERATE Volunteer Registry can access the registration questionnaire via http://www.vaccelerate.eu/volunteer-registry. Potential volunteers are requested to provide their current country and area of residence, contact information, including first and last name and e-mail address, age, gender, comorbidities, previous SARS-CoV-2 infection and vaccination status, and maximum distance willing to travel to a clinical trial site. The registry is open to both adults and children, complying with national legal consent requirements. Results: As of May 2022, the questionnaire is available in 12 countries and 14 languages. Up to date, more than 36,000 volunteers have registered, mainly from Germany. Within the first year since its establishment, the VACCELERATE Volunteer Registry has matched more than 15,000 volunteers to clinical trials. The VACCELERATE Volunteer Registry will be launched in further European countries in the coming months. Conclusions: The VACCELERATE Volunteer Registry is an active single-entry point for European residents interested in COVID-19 clinical trials participation in 12 countries (i.e., Austria, Cyprus, Germany, Greece, Ireland, Lithuania, Norway, Portugal, Spain, Sweden and Turkey). To date, more than 15,000 registered individuals have been connected to clinical trials in Germany alone. The registry is currently in the implementation phase in 5 additional countries (i.e., Belgium, Czech Republic, Hungary, Israel and the Netherlands). The German Volunteer Registry receives funding from the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) specifically grant BMBF01KX2040. The VACCELERATE Volunteer Registry, i.e., registries outside Germany, has received funding from the European Union’s Horizon 2020 research and innovation programme (grant agreement No 101037867). Sí
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- 2022
4. Fungus-Specific CD4+ T Cells for Rapid Identification of Invasive Pulmonary Mold Infection
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Bacher, Petra, Steinbach, Angela, Kniemeyer, Olaf, Hamprecht, Axel, Assenmacher, Mario, Vehreschild, Maria J. G. T., Vehreschild, Jörg J., Brakhage, Axel A., Cornely, Oliver A., and Scheffold, Alexander
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- 2015
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5. Mould-reactive T cells for the diagnosis of invasive mould infection-A prospective study
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Steinbach, Angela, Cornely, Oliver A., Wisplinghoff, Hilmar, Schauss, Astrid C., Vehreschild, Joerg J., Rybniker, Jan, Hamprecht, Axel, Richter, Anne, Bacher, Petra, Scheffold, Alexander, Koehler, Philipp, Steinbach, Angela, Cornely, Oliver A., Wisplinghoff, Hilmar, Schauss, Astrid C., Vehreschild, Joerg J., Rybniker, Jan, Hamprecht, Axel, Richter, Anne, Bacher, Petra, Scheffold, Alexander, and Koehler, Philipp
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Invasive mould infections (IMI) in immunocompromised patients are difficult to diagnose. Early and targeted treatment is paramount, but minimally invasive tests reliably identifying pathogens are lacking. We previously showed that monitoring pathogen-specific CD4+T cells in peripheral blood using upregulation of induced CD154 positive lymphocytes can be used to diagnose acute IMI. Here, we validate our findings in an independent patient cohort. We stimulated peripheral blood cells from at-risk patients with Aspergillus spp. and Mucorales lysates and quantitated mould-reactive CD4/CD69/CD154 positive lymphocytes via flow cytometry. Mould-reactive lymphocytes were quantitated in 115 at-risk patients. In 38 (33%) patients, the test was not evaluable, mainly due to low T cell counts or non-reactive positive control. Test results were evaluable in 77 (67%) patients. Of these, four patients (5%) had proven IMI and elevated mould-reactive T cell signals. Of 73 (95%) patients without proven IMI, 59 (81%) had mould-reactive T cell signals within normal range. Fourteen (19%) patients without confirmed IMI showed elevated T cell signals and 11 of those received antifungal treatment. The mould-reactive lymphocyte assay identified presence of IMI with a sensitivity of 100% and specificity of 81%. The mould-reactive lymphocyte assay correctly identified all patients with proven IMI. Assay applicability is limited by low T cell counts during bone marrow suppression. The assay has the potential to support diagnosis of invasive mould infection to facilitate tailored treatment even when biopsies are contraindicated or cultures remain negative.
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- 2019
6. Baseline predictors influencing the prognosis of invasive aspergillosis in adults
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Koehler, Philipp, Salmanton-Garcia, Jon, Graefe, Stefanie K., Koehler, Felix C., Mellinghoff, Sibylle C., Seidel, Danila, Steinbach, Angela, Cornely, Oliver A., Koehler, Philipp, Salmanton-Garcia, Jon, Graefe, Stefanie K., Koehler, Felix C., Mellinghoff, Sibylle C., Seidel, Danila, Steinbach, Angela, and Cornely, Oliver A.
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Invasive aspergillosis (IA) is a serious hazard to haematological and critical care patients. Impactful risk factors for developing IA have been characterised; however, systematic analysis of baseline prognostic factors for treatment course of IA is missing. To understand prognostic variables, we analysed original articles identifying baseline factors that predict treatment outcome in patients with IA. PubMed database was searched for publications since database inception until May 2018. Inclusion criteria were published baseline prognostic factors present at the diagnosis of IA. In total, 58 studies from 267 centres reported 7320 patients with IA and 40 different predictors. Unfavourable predictors in medical history were kidney (7.4%, 10/136) and liver failure (3.7%, 5/136), ICU admission (3.7%, 5/136) and uncontrolled underlying disease (3.7%, 5/136). Regarding state of immunosuppression, negative outcome predictors were prolonged neutropenia (12.5%, 17/136), corticosteroid treatment (8.1%, 11/136) and graft-vs-host disease (3.7%, 5/136). On the pathogen side, relevant predictors were galactomannan positivity (8.1%, 11/136), Aspergillus terreus infection (2.2%, 3/136) and lack of amphotericin B susceptibility (1.5%, 2/136). IA-specific predictors were disseminated disease (5.1%, 7/136) and CNS involvement (2.9%, 4/136). Imaging results associated with negative outcome were multiple consolidations (2.9%, 4/136), bipulmonary lesions (2.2%, 3/136) and pleural effusion (2.2%, 3/136). At diagnosis of IA, most frequently identified predictors of outcome were neutropenia, corticosteroid use, elevated galactomannan, renal failure and disseminated disease. The predictors may be used to identify patients at high risk for treatment failure and to stratify neglected patient groups for clinical trials.
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- 2019
7. Intracellular Concentrations of Posaconazole in Different Compartments of Peripheral Blood
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Farowski, Fedja, primary, Cornely, Oliver A., additional, Vehreschild, Jörg J., additional, Hartmann, Pia, additional, Bauer, Tim, additional, Steinbach, Angela, additional, Rüping, Maria J. G. T., additional, and Müller, Carsten, additional
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- 2010
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8. Quantitation of Azoles and Echinocandins in Compartments of Peripheral Blood by Liquid Chromatography-Tandem Mass Spectrometry
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Farowski, Fedja, primary, Cornely, Oliver A., additional, Vehreschild, Jörg J., additional, Hartmann, Pia, additional, Bauer, Tim, additional, Steinbach, Angela, additional, Rüping, Maria J. G. T., additional, and Müller, Carsten, additional
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- 2010
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9. Fungus-Specific CD4+T Cells for Rapid Identification of Invasive Pulmonary Mold Infection.
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Bacher, Petra, Steinbach, Angela, Kniemeyer, Olaf, Hamprecht, Axel, Assenmacher, Mario, Vehreschild, Maria J. G. T., Vehreschild, Jörg J., Brakhage, Axel A., Cornely, Oliver A., and Scheffold, Jörg J. Vehreschild
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- 2015
- Full Text
- View/download PDF
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