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1. Real-world experience with letermovir for cytomegalovirus-prophylaxis after allogeneic hematopoietic cell transplantation: A multi-centre observational study

Author

Hopff, Sina M., Wingen-Heimann, Sebastian M., Classen, Annika Y., Blau, Igor-Wolfgang, Bug, Gesine, Hebermehl, Corinna, Kraus, Sabrina, Penack, Olaf, Rettig, Andrés R., Schmitt, Timo, Steinbrunn, Torsten, Teschner, Daniel, Vehreschild, Maria J.G.T., Wehr, Claudia, and Vehreschild, J. Janne

Published
2024
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2. A phase 3, randomised, observer-blinded, placebo controlled-trial evaluating the safety and immunogenicity of investigational SARS-CoV-2 mRNA vaccine CVnCoV in adult healthcare workers in Mainz (Germany)

Author

Kowalzik, Frank, Teschner, Daniel, Mesquita, Margarida, Jensen, Christian, Schreiner, Daniel, Kronfeld, Kai, Tubic-Grozdanis, Marija, Cheatham-Seitz, Darline, Hettich, Franziska, Quintini, Gianluca, Schoenborn-Kellenberger, Oliver, Codó, Paula, von Eisenhart-Rothe, Philipp, Mann, Philipp, Oostvogels, Lidia, and Gehring, Stephan

Published
2024
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7. Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial

Author

Akova, Murat, AlAgha, Rawan, Alangaden, George, Albrecht, Svenja J, Alexander, Barbara, Al-Obaidi, Mohanad, Ambasch, German, Armestar Rodriguez, Fernando, Azap, Alpay, Baffoe-Bonnie, Anthony, Belkhir, Leila, Ben-Ami, Ronen, Boutoille, David, Cascio, Antonio, Chai, Louis YA, Chaiwarith, Romanee, Chayakulkeeree, Methee, Chen, Sharon, Chen, Yee-Chun, Chen, Yen-Hsu, Choi, Jun Yong, Choi, Young Hwa, Chotiprasitsakul, Darunee, Chung, Jin Won, Danion, François, Denis, Blandine, Diaz Santos, Emilio, Dictar, Miguel O, Diltoer, Marc, Dupont, Herve, Feng, Sizhou, Ferre Colomer, Maria Angeles, Ferrer, Ricard, Forel, Jean-Marie Fernand Roger, Fortún-Abete, Jesús, Garcia-Diaz, Julia, Girardis, Massimo, He, Fang, Hites, Maya, Ho, Mao-Wang, Honore, Patrick, Horcajada Gallego, Juan Pablo, Huang, Haihui, Huang, Po-Yen, Huang, Yong, Hussein, Osamah, Intalapaporn, Poj, Jaruratanasirikul, Sutep, Jauregui-Peredo, Luis, Johnson, Misty, Jung, Dong Sik, Jutivorakool, Kamonwan, Kern, Winfried V, Kett, Daniel H, Khawcharoenporn, Thana, Kim, Young Keun, Koehler, Philipp, Kotanidou, Anastasia, Lachiewicz, Anne, Lin, Qinhan, Lopez Cortes, Luis Eduardo, Luo, Hong, Luzzati, Roberto, Maor, Yasmin, McCarty, Todd, Merelli, Maria, Merino Amador, Paloma, Midturi, John, Migliorino, Guglielmo Marco, Mira, Jean-Paul, Mootsikapun, Piroon, Morrissey, Orla, Munoz Garcia de Paredes, Patricia, Mussini, Cristina, Mylonakis, Eleftherios, Nseir, Saadalla, Nseir, William, Odabasi, Zekaver, Papastamopoulos, Vasileios, Paterson, David, Patterson, Thomas F, Peck, Kyong Ran, Peng, Zhiyong, Permpalung, Nitipong, Plantefeve, Gaetan J, Poromanski, Ivan G, Powell, Debra, Psichogiou, Mina, Puah, Ser Hon, Pullman, John, Rahav, Galia, Martinez, Antonio Ramos, Ramos Ramos, Juan Carlos, Raz-Pasteur, Ayelet, Restrepo Castro, Carlos A, Riera, Fernando, Roblot, France, Rodriguez Alvarez, Regino Jose, Rogers, Benjamin, Roilides, Emmanuel, Sanchez Vallejo, Gregorio, Sganga, Gabriele, Sipsas, Nikolaos, Slavin, Monica, Soriano, Alex, Spec, Andrej, Strahilevitz, Jacob, Tancheva, Dora M, Tao, Zhen, Teschner, Daniel, Thompson, George R, Van Wijngaerden, Eric, Vazquez, Jose, Vergidis, Paschalis, Viale, Pierluigi, Wang, Fu-Der, Wang, Shifu, Weber, Gabriel, Weng, Jianyu, Xu, Jinfu, Yao, Li, Yavuz, Serap, Yilmaz, Mesut, Young, Jo-Anne, Zarate, Abel H, Zeng, Jun, Zhang, Yong, Thompson, George R, III, Cornely, Oliver A, Kullberg, Bart Jan, Kollef, Marin, Honore, Patrick M, Bassetti, Matteo, Poromanski, Ivan, Dignani, Cecilia, Das, Anita F, Sandison, Taylor, and Pappas, Peter G

Published
2023
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9. Prevention of CMV/EBV reactivation by double-specific T cells in patients after allogeneic stem cell transplantation: results from the randomized phase I/IIa MULTIVIR-01 study

Author

Gerbitz, Armin, primary, Gary, Regina, additional, Aigner, Michael, additional, Moosmann, Andreas, additional, Kremer, Anita, additional, Schmid, Christoph, additional, Hirschbuehl, Klaus, additional, Wagner, Eva, additional, Hauptrock, Beate, additional, Teschner, Daniel, additional, Roesler, Wolf, additional, Spriewald, Bernd, additional, Tischer, Johanna, additional, Moi, Stephanie, additional, Balzer, Heidi, additional, Schaffer, Stefanie, additional, Bausenwein, Judith, additional, Wagner, Anja, additional, Schmidt, Franziska, additional, Brestrich, Jens, additional, Ullrich, Barbara, additional, Maas, Stefanie, additional, Herold, Susanne, additional, Strobel, Julian, additional, Zimmermann, Robert, additional, Weisbach, Volker, additional, Hansmann, Leo, additional, Lammoglia-Cobo, Fernanda, additional, Remberger, Mats, additional, Stelljes, Matthias, additional, Ayuk, Francis, additional, Zeiser, Robert, additional, and Mackensen, Andreas, additional

Published
2023
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10. Chlorhexidine gluconate‐coated gel pad dressings for prevention of central venous catheter‐related bloodstream infections in patients with hematologic diseases or autologous stem cell transplantation: A registry‐based matched‐pair analysis

Author

Teschner, Daniel, primary, Berisha, Mirjeta, additional, Panse, Jens, additional, Schmitt, Timo, additional, Fiegle, Eva, additional, Naendrup, Jan‐Hendrik, additional, Neitz, Julia, additional, Schmidt‐Hieber, Martin, additional, Hentrich, Marcus, additional, Böll, Boris, additional, and Schalk, Enrico, additional

Published
2023
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11. Primary prophylaxis of invasive fungal diseases in patients with haematological malignancies: 2022 update of the recommendations of the Infectious Diseases Working Party (AGIHO) of the German Society for Haematology and Medical Oncology (DGHO)

Author

Stemler, Jannik, primary, Mellinghoff, Sibylle C, additional, Khodamoradi, Yascha, additional, Sprute, Rosanne, additional, Classen, Annika Y, additional, Zapke, Sonja E, additional, Hoenigl, Martin, additional, Krause, Robert, additional, Schmidt-Hieber, Martin, additional, Heinz, Werner J, additional, Klein, Michael, additional, Koehler, Philipp, additional, Liss, Blasius, additional, Koldehoff, Michael, additional, Buhl, Christoph, additional, Penack, Olaf, additional, Maschmeyer, Georg, additional, Schalk, Enrico, additional, Lass-Flörl, Cornelia, additional, Karthaus, Meinolf, additional, Ruhnke, Markus, additional, Cornely, Oliver A, additional, and Teschner, Daniel, additional

Published
2023
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13. Phase 1b safety and pharmacokinetics of intravenous and oral fosmanogepix in patients with acute myeloid leukaemia and neutropenia.

Author

Cornely, Oliver A, Ostermann, Helmut, Koehler, Philipp, Teschner, Daniel, Limburg, Endrik, Kramer, William G, Barbat, Sara H, Tawadrous, Margaret, and Hodges, Michael R

Subjects
ACUTE myeloid leukemia, FUNGAL cell walls, CD4 lymphocyte count, INDUCTION chemotherapy, PATIENT experience, REMISSION induction
Abstract

Objectives Fosmanogepix (APX001), a first-in-class, intravenous (IV) and oral (PO) antifungal prodrug, is being developed to treat invasive fungal diseases (IFDs). Manogepix (APX001A; active moiety) targets fungal glycosylphosphatidylinositol-anchored cell wall transfer protein 1, inhibiting cell wall synthesis causing loss of viability. This open-label, multicentre, Phase 1b study in patients with AML and neutropenia (absolute neutrophil count <500 cells/μL; >10 days) undergoing chemotherapy aimed to assess tolerability, safety and pharmacokinetics (PK) of IV and PO fosmanogepix. Methods Of 21 adult AML patients undergoing remission induction chemotherapy, 10 received IV fosmanogepix (600 mg; q24h) and 11 received oral fosmanogepix (500 mg; q24h) over 14 days, with a 28 day follow-up. Patients also received remission induction chemotherapy [sequential high-dose cytarabine and mitoxantrone (S-HAM) or 7 + 3 regimen] for AML and IFD prophylaxis (posaconazole). A two-compartmental PK model from previous studies in healthy volunteers was fitted to manogepix plasma data. Results Of 26 fosmanogepix-related adverse events (AEs; IV: 14; PO: 12) in 9 (42.9%) patients [IV: 5 (50%); PO: 4 (36.4%)], none were serious or resulted in fosmanogepix discontinuation. Most frequently occurring fosmanogepix-related AEs were Grade 1/2 nausea [four events in three patients (14.3%)]; vomiting, ALT increase, and delirium [two events; two patients (9.5%) each]. One patient experienced fosmanogepix-related Grade 3 hypertension. Dose-corrected geometric mean ratio of AUC (PO-to-IV) was 95%. Elimination half-lives (∼2 days) were consistent with prior studies in healthy volunteers. Conclusions Fosmanogepix was safe and well tolerated in AML patients with neutropenia receiving remission induction chemotherapy. Safety and PK profiles were comparable to healthy volunteers. [ABSTRACT FROM AUTHOR]

Published
2023
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14. Primary prophylaxis of invasive fungal infections in patients with haematological malignancies: 2017 update of the recommendations of the Infectious Diseases Working Party (AGIHO) of the German Society for Haematology and Medical Oncology (DGHO)

Author

Mellinghoff, Sibylle C., Panse, Jens, Alakel, Nael, Behre, Gerhard, Buchheidt, Dieter, Christopeit, Maximilian, Hasenkamp, Justin, Kiehl, Michael, Koldehoff, Michael, Krause, Stefan W., Lehners, Nicola, von Lilienfeld-Toal, Marie, Löhnert, Annika Y., Maschmeyer, Georg, Teschner, Daniel, Ullmann, Andrew J., Penack, Olaf, Ruhnke, Markus, Mayer, Karin, Ostermann, Helmut, Wolf, Hans-H., and Cornely, Oliver A.

Published
2017
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15. Performance of T-Track® TB, a Novel Dual Marker RT-qPCR-Based Whole-Blood Test for Improved Detection of Active Tuberculosis

Author

Meier, Johannes P., primary, Möbus, Selina, additional, Heigl, Florian, additional, Asbach-Nitzsche, Alexandra, additional, Niller, Hans Helmut, additional, Plentz, Annelie, additional, Avsar, Korkut, additional, Heiß-Neumann, Marion, additional, Schaaf, Bernhard, additional, Cassens, Uwe, additional, Seese, Bernd, additional, Teschner, Daniel, additional, Handzhiev, Sabin, additional, Graf, Uwe, additional, Lübbert, Christoph, additional, Steinmaurer, Monika, additional, Kontogianni, Konstantina, additional, Berg, Christoph, additional, Maieron, Andreas, additional, Blaas, Stefan H., additional, Wagner, Ralf, additional, Deml, Ludwig, additional, and Barabas, Sascha, additional

Published
2023
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16. Prevention of CMV/EBV reactivation by double-specific T cells in patients after allogeneic stem cell transplantation : results from the randomized phase I/IIa MULTIVIR-01 study

Author

Gerbitz, Armin, Gary, Regina, Aigner, Michael, Moosmann, Andreas, Kremer, Anita, Schmid, Christoph, Hirschbuehl, Klaus, Wagner, Eva, Hauptrock, Beate, Teschner, Daniel, Roesler, Wolf, Spriewald, Bernd, Tischer, Johanna, Moi, Stephanie, Balzer, Heidi, Schaffer, Stefanie, Bausenwein, Judith, Wagner, Anja, Schmidt, Franziska, Brestrich, Jens, Ullrich, Barbara, Maas, Stefanie, Herold, Susanne, Strobel, Julian, Zimmermann, Robert, Weisbach, Volker, Hansmann, Leo, Lammoglia-Cobo, Fernanda, Remberger, Mats, Stelljes, Matthias, Ayuk, Francis, Zeiser, Robert, Mackensen, Andreas, Gerbitz, Armin, Gary, Regina, Aigner, Michael, Moosmann, Andreas, Kremer, Anita, Schmid, Christoph, Hirschbuehl, Klaus, Wagner, Eva, Hauptrock, Beate, Teschner, Daniel, Roesler, Wolf, Spriewald, Bernd, Tischer, Johanna, Moi, Stephanie, Balzer, Heidi, Schaffer, Stefanie, Bausenwein, Judith, Wagner, Anja, Schmidt, Franziska, Brestrich, Jens, Ullrich, Barbara, Maas, Stefanie, Herold, Susanne, Strobel, Julian, Zimmermann, Robert, Weisbach, Volker, Hansmann, Leo, Lammoglia-Cobo, Fernanda, Remberger, Mats, Stelljes, Matthias, Ayuk, Francis, Zeiser, Robert, and Mackensen, Andreas

Abstract

IntroductionAllogeneic stem cell transplantation is used to cure hematologic malignancies or deficiencies of the hematopoietic system. It is associated with severe immunodeficiency of the host early after transplant and therefore early reactivation of latent herpesviruses such as CMV and EBV within the first 100 days are frequent. Small studies and case series indicated that application of herpes virus specific T cells can control and prevent disease in this patient population.MethodsWe report the results of a randomized controlled multi centre phase I/IIa study (MULTIVIR-01) using a newly developed T cell product with specificity for CMV and EBV derived from the allogeneic stem cell grafts used for transplantation. The study aimed at prevention and preemptive treatment of both viruses in patients after allogeneic stem cell transplantation targeting first infusion on day +30. Primary endpoints were acute transfusion reaction and acute-graft versus-host-disease after infusion of activated T cells.ResultsThirty-three patients were screened and 9 patients were treated with a total of 25 doses of the T cell product. We show that central manufacturing can be achieved successfully under study conditions and the product can be applied without major side effects. Overall survival, transplant related mortality, cumulative incidence of graft versus host disease and number of severe adverse events were not different between treatment and control groups. Expansion of CMV/EBV specific T cells was observed in a fraction of patients, but overall there was no difference in virus reactivation.DiscussionOur study results indicate peptide stimulated epitope specific T cells derived from stem cell grafts can be administered safely for prevention and preemptive treatment of reactivation without evidence for induction of acute graft versus host disease.Clinical trial registrationhttps://clinicaltrials.gov, identifier NCT02227641.

Published
2023
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17. Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial

Author

Thompson, George R, primary, Soriano, Alex, additional, Cornely, Oliver A, additional, Kullberg, Bart Jan, additional, Kollef, Marin, additional, Vazquez, Jose, additional, Honore, Patrick M, additional, Bassetti, Matteo, additional, Pullman, John, additional, Chayakulkeeree, Methee, additional, Poromanski, Ivan, additional, Dignani, Cecilia, additional, Das, Anita F, additional, Sandison, Taylor, additional, Pappas, Peter G, additional, Akova, Murat, additional, AlAgha, Rawan, additional, Alangaden, George, additional, Albrecht, Svenja J, additional, Alexander, Barbara, additional, Al-Obaidi, Mohanad, additional, Ambasch, German, additional, Armestar Rodriguez, Fernando, additional, Azap, Alpay, additional, Baffoe-Bonnie, Anthony, additional, Belkhir, Leila, additional, Ben-Ami, Ronen, additional, Boutoille, David, additional, Cascio, Antonio, additional, Chai, Louis YA, additional, Chaiwarith, Romanee, additional, Chen, Sharon, additional, Chen, Yee-Chun, additional, Chen, Yen-Hsu, additional, Choi, Jun Yong, additional, Choi, Young Hwa, additional, Chotiprasitsakul, Darunee, additional, Chung, Jin Won, additional, Danion, François, additional, Denis, Blandine, additional, Diaz Santos, Emilio, additional, Dictar, Miguel O, additional, Diltoer, Marc, additional, Dupont, Herve, additional, Feng, Sizhou, additional, Ferre Colomer, Maria Angeles, additional, Ferrer, Ricard, additional, Forel, Jean-Marie Fernand Roger, additional, Fortún-Abete, Jesús, additional, Garcia-Diaz, Julia, additional, Girardis, Massimo, additional, He, Fang, additional, Hites, Maya, additional, Ho, Mao-Wang, additional, Honore, Patrick, additional, Horcajada Gallego, Juan Pablo, additional, Huang, Haihui, additional, Huang, Po-Yen, additional, Huang, Yong, additional, Hussein, Osamah, additional, Intalapaporn, Poj, additional, Jaruratanasirikul, Sutep, additional, Jauregui-Peredo, Luis, additional, Johnson, Misty, additional, Jung, Dong Sik, additional, Jutivorakool, Kamonwan, additional, Kern, Winfried V, additional, Kett, Daniel H, additional, Khawcharoenporn, Thana, additional, Kim, Young Keun, additional, Koehler, Philipp, additional, Kotanidou, Anastasia, additional, Lachiewicz, Anne, additional, Lin, Qinhan, additional, Lopez Cortes, Luis Eduardo, additional, Luo, Hong, additional, Luzzati, Roberto, additional, Maor, Yasmin, additional, McCarty, Todd, additional, Merelli, Maria, additional, Merino Amador, Paloma, additional, Midturi, John, additional, Migliorino, Guglielmo Marco, additional, Mira, Jean-Paul, additional, Mootsikapun, Piroon, additional, Morrissey, Orla, additional, Munoz Garcia de Paredes, Patricia, additional, Mussini, Cristina, additional, Mylonakis, Eleftherios, additional, Nseir, Saadalla, additional, Nseir, William, additional, Odabasi, Zekaver, additional, Papastamopoulos, Vasileios, additional, Paterson, David, additional, Patterson, Thomas F, additional, Peck, Kyong Ran, additional, Peng, Zhiyong, additional, Permpalung, Nitipong, additional, Plantefeve, Gaetan J, additional, Poromanski, Ivan G, additional, Powell, Debra, additional, Psichogiou, Mina, additional, Puah, Ser Hon, additional, Rahav, Galia, additional, Martinez, Antonio Ramos, additional, Ramos Ramos, Juan Carlos, additional, Raz-Pasteur, Ayelet, additional, Restrepo Castro, Carlos A, additional, Riera, Fernando, additional, Roblot, France, additional, Rodriguez Alvarez, Regino Jose, additional, Rogers, Benjamin, additional, Roilides, Emmanuel, additional, Sanchez Vallejo, Gregorio, additional, Sganga, Gabriele, additional, Sipsas, Nikolaos, additional, Slavin, Monica, additional, Spec, Andrej, additional, Strahilevitz, Jacob, additional, Tancheva, Dora M, additional, Tao, Zhen, additional, Teschner, Daniel, additional, Thompson, George R, additional, Van Wijngaerden, Eric, additional, Vergidis, Paschalis, additional, Viale, Pierluigi, additional, Wang, Fu-Der, additional, Wang, Shifu, additional, Weber, Gabriel, additional, Weng, Jianyu, additional, Xu, Jinfu, additional, Yao, Li, additional, Yavuz, Serap, additional, Yilmaz, Mesut, additional, Young, Jo-Anne, additional, Zarate, Abel H, additional, Zeng, Jun, additional, and Zhang, Yong, additional

Published
2023
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18. Primary prophylaxis of invasive fungal diseases in patients with haematological malignancies : 2022 update of the recommendations of the Infectious Diseases Working Party (AGIHO) of the German Society for Haematology and Medical Oncology (DGHO)

Author

Stemler, Jannik, Mellinghoff, Sibylle C, Khodamoradi, Yascha, Sprute, Rosanne, Classen, Annika Y, Zapke, Sonja E, Hoenigl, Martin, Krause, Robert, Schmidt-Hieber, Martin, Heinz, Werner J, Klein, Michael, Koehler, Philipp, Liss, Blasius, Koldehoff, Michael, Buhl, Christoph, Penack, Olaf, Maschmeyer, Georg, Schalk, Enrico, Lass-Flörl, Cornelia, Karthaus, Meinolf, Ruhnke, Markus, Cornely, Oliver A, and Teschner, Daniel

Subjects
Medizin
Abstract

in press

Published
2023

20. Parainfluenza virus infections in patients with hematological malignancies or stem cell transplantation: Analysis of clinical characteristics, nosocomial transmission and viral shedding

Author

Tabatabai, Julia, primary, Schnitzler, Paul, additional, Prifert, Christiane, additional, Schiller, Martin, additional, Weissbrich, Benedikt, additional, von Lilienfeld-Toal, Marie, additional, Teschner, Daniel, additional, Jordan, Karin, additional, Müller-Tidow, Carsten, additional, Egerer, Gerlinde, additional, and Giesen, Nicola, additional

Published
2022
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22. Central venous catheter-related bloodstream infections in patients with haematological malignancies during the SARS-CoV-2 pandemic

Author

Schalk, Enrico, Schmitt, Timo, Panse, Jens, Fiegle, Eva, Naendrup, Jan-Hendrik, Schmidt-Hieber, Martin, Boell, Boris, Hentrich, Marcus, Teschner, Daniel, Mougiakakos, Dimitrios, Schalk, Enrico, Schmitt, Timo, Panse, Jens, Fiegle, Eva, Naendrup, Jan-Hendrik, Schmidt-Hieber, Martin, Boell, Boris, Hentrich, Marcus, Teschner, Daniel, and Mougiakakos, Dimitrios

Published
2022

23. Performance of T-Track ® TB, a Novel Dual Marker RT-qPCR-Based Whole-Blood Test for Improved Detection of Active Tuberculosis.

Author

Meier, Johannes P., Möbus, Selina, Heigl, Florian, Asbach-Nitzsche, Alexandra, Niller, Hans Helmut, Plentz, Annelie, Avsar, Korkut, Heiß-Neumann, Marion, Schaaf, Bernhard, Cassens, Uwe, Seese, Bernd, Teschner, Daniel, Handzhiev, Sabin, Graf, Uwe, Lübbert, Christoph, Steinmaurer, Monika, Kontogianni, Konstantina, Berg, Christoph, Maieron, Andreas, and Blaas, Stefan H.

Subjects
TUBERCULOSIS, ENZYME-linked immunosorbent assay, COMMUNICABLE diseases
Abstract

Tuberculosis (TB) is one of the leading causes of death by an infectious disease. It remains a major health burden worldwide, in part due to misdiagnosis. Therefore, improved diagnostic tests allowing the faster and more reliable diagnosis of patients with active TB are urgently needed. This prospective study examined the performance of the new molecular whole-blood test T-Track® TB, which relies on the combined evaluation of IFNG and CXCL10 mRNA levels, and compared it to that of the QuantiFERON®-TB Gold Plus (QFT-Plus) enzyme-linked immunosorbent assay (ELISA). Diagnostic accuracy and agreement analyses were conducted on the whole blood of 181 active TB patients and 163 non-TB controls. T-Track® TB presented sensitivity of 94.9% and specificity of 93.8% for the detection of active TB vs. non-TB controls. In comparison, the QFT-Plus ELISA showed sensitivity of 84.3%. The sensitivity of T-Track® TB was significantly higher (p < 0.001) than that of QFT-Plus. The overall agreement of T-Track® TB with QFT-Plus to diagnose active TB was 87.9%. Out of 21 samples with discordant results, 19 were correctly classified by T-Track® TB while misclassified by QFT-Plus (T-Track® TB-positive/QFT-Plus-negative), and two samples were misclassified by T-Track® TB while correctly classified by QFT-Plus (T-Track® TB-negative/QFT-Plus-positive). Our results demonstrate the excellent performance of the T-Track® TB molecular assay and its suitability to accurately detect TB infection and discriminate active TB patients from non-infected controls. [ABSTRACT FROM AUTHOR]

Published
2023
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24. Comparison of Cytomegalovirus-Specific Immune Cell Response to Proteins versus Peptides Using an IFN-γ ELISpot Assay after Hematopoietic Stem Cell Transplantation

Author

Wolff, Daniel, Wagner-Drouet, Eva Maria, Teschner, Daniel, Wolschke, Christine, Schäfer-Eckart, Kerstin, Gärtner, Johannes, Mielke, Stephan, Schreder, Martin, Kobbe, Guido, Hilgendorf, Inken, Klein, Stefan, Verbeek, Mareike, Ditschkowski, Markus, Koch, Martina, Lindemann, Monika, Schmidt, Traudel, Rascle, Anne, Barabas, Sascha, Deml, Ludwig, and Wagner, Ralf

Subjects
ddc:610, lcsh:R5-920, immune monitoring, immunosuppression, 610 Medizin, Medizin, CMV, T cells, CMV-specific cellular immunity, hematopoietic stem cell transplantation, recall antigen, peptide, IFN-γ ELISpot, antigen processing and presentation, virus diseases, Article, lcsh:Medicine (General)
Abstract

Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality following hematopoietic stem cell transplantation (HSCT). Measuring CMV-specific cellular immunity may improve the risk stratification and management of patients. IFN-γ ELISpot assays, based on the stimulation of peripheral blood mononuclear cells with CMV pp65 and IE-1 proteins or peptides, have been validated in clinical settings. However, it remains unclear to which extend the T-cell response to synthetic peptides reflect that mediated by full-length proteins processed by antigen-presenting cells. We compared the stimulating ability of pp65 and IE-1 proteins and corresponding overlapping peptides in 16 HSCT recipients using a standardized IFN-γ ELISpot assay. Paired qualitative test results showed an overall 74.4% concordance. Discordant results were mainly due to low-response tests, with one exception. One patient with early CMV reactivation and graft-versus-host disease, sustained CMV DNAemia and high CD8+ counts showed successive negative protein-based ELISpot results but a high and sustained response to IE-1 peptides. Our results suggest that the response to exogenous proteins, which involves their uptake and processing by antigen-presenting cells, more closely reflects the physiological response to CMV infection, while the response to exogenous peptides may lead to artificial in vitro T-cell responses, especially in strongly immunosuppressed patients.

Published
2021

27. mRNA-Based Vaccines

Author

Kowalzik, Frank, primary, Schreiner, Daniel, additional, Jensen, Christian, additional, Teschner, Daniel, additional, Gehring, Stephan, additional, and Zepp, Fred, additional

Published
2021
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28. Comparison of Cytomegalovirus-Specific Immune Cell Response to Proteins versus Peptides Using an IFN-γ ELISpot Assay after Hematopoietic Stem Cell Transplantation

Author

Wagner-Drouet, Eva, primary, Teschner, Daniel, additional, Wolschke, Christine, additional, Schäfer-Eckart, Kerstin, additional, Gärtner, Johannes, additional, Mielke, Stephan, additional, Schreder, Martin, additional, Kobbe, Guido, additional, Hilgendorf, Inken, additional, Klein, Stefan, additional, Verbeek, Mareike, additional, Ditschkowski, Markus, additional, Koch, Martina, additional, Lindemann, Monika, additional, Schmidt, Traudel, additional, Rascle, Anne, additional, Barabas, Sascha, additional, Deml, Ludwig, additional, Wagner, Ralf, additional, and Wolff, Daniel, additional

Published
2021
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31. Central venous catheter-related bloodstream infections in patients with hematological malignancies: Comparison of data from a clinical registry and a randomized controlled trial

Author

Schalk, Enrico, Teschner, Daniel, Hentrich, Marcus, Boell, Boris, Panse, Jens, Schmidt-Hieber, Martin, Vehreschild, Maria J. G. T., Biehl, Lena M., Schalk, Enrico, Teschner, Daniel, Hentrich, Marcus, Boell, Boris, Panse, Jens, Schmidt-Hieber, Martin, Vehreschild, Maria J. G. T., and Biehl, Lena M.

Published
2020

32. Treatment of invasive fungal diseases in cancer patients-Revised 2019 Recommendations of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO)

Author

Ruhnke, Markus, Cornely, Oliver A., Schmidt-Hieber, Martin, Alakel, Nael, Boell, Boris, Buchheidt, Dieter, Christopeit, Maximilian, Hasenkamp, Justin, Heinz, Werner J., Hentrich, Marcus, Karthaus, Meinolf, Koldehoff, Michael, Maschmeyer, Grorg, Panse, Jens, Penack, Olaf, Schleicher, Jan, Teschner, Daniel, Ullmann, Andrew John, Vehreschild, Maria, von Lilienfeld-Toal, Marie, Weissinger, Florian, Schwartz, Stefan, Ruhnke, Markus, Cornely, Oliver A., Schmidt-Hieber, Martin, Alakel, Nael, Boell, Boris, Buchheidt, Dieter, Christopeit, Maximilian, Hasenkamp, Justin, Heinz, Werner J., Hentrich, Marcus, Karthaus, Meinolf, Koldehoff, Michael, Maschmeyer, Grorg, Panse, Jens, Penack, Olaf, Schleicher, Jan, Teschner, Daniel, Ullmann, Andrew John, Vehreschild, Maria, von Lilienfeld-Toal, Marie, Weissinger, Florian, and Schwartz, Stefan

Abstract

Background Invasive fungal diseases remain a major cause of morbidity and mortality in cancer patients undergoing intensive cytotoxic therapy. The choice of the most appropriate antifungal treatment (AFT) depends on the fungal species suspected or identified, the patient's risk factors (eg length and depth of granulocytopenia) and the expected side effects. Objectives Since the last edition of recommendations for 'Treatment of invasive fungal infections in cancer patients' of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO) in 2013, treatment strategies were gradually moving away from solely empirical therapy of presumed or possible invasive fungal diseases (IFDs) towards pre-emptive therapy of probable IFD. Methods The guideline was prepared by German clinical experts for infections in cancer patients in a stepwise consensus process. MEDLINE was systematically searched for English-language publications from January 1975 up to September 2019 using the key terms such as 'invasive fungal infection' and/or 'invasive fungal disease' and at least one of the following: antifungal agents, cancer, haematological malignancy, antifungal therapy, neutropenia, granulocytopenia, mycoses, aspergillosis, candidosis and mucormycosis. Results AFT of IFDs in cancer patients may include not only antifungal agents but also non-pharmacologic treatment. In addition, the armamentarium of antifungals for treatment of IFDs has been broadened (eg licensing of isavuconazole). Additional antifungals are currently under investigation or in clinical trials. Conclusions Here, updated recommendations for the treatment of proven or probable IFDs are given. All recommendations including the levels of evidence are summarised in tables to give the reader rapid access to key information.

Published
2020

36. Treatment of invasive fungal diseases in cancer patients—Revised 2019 Recommendations of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO)

Author

Ruhnke, Markus, primary, Cornely, Oliver A., additional, Schmidt‐Hieber, Martin, additional, Alakel, Nael, additional, Boell, Boris, additional, Buchheidt, Dieter, additional, Christopeit, Maximilian, additional, Hasenkamp, Justin, additional, Heinz, Werner J., additional, Hentrich, Marcus, additional, Karthaus, Meinolf, additional, Koldehoff, Michael, additional, Maschmeyer, Georg, additional, Panse, Jens, additional, Penack, Olaf, additional, Schleicher, Jan, additional, Teschner, Daniel, additional, Ullmann, Andrew John, additional, Vehreschild, Maria, additional, Lilienfeld‐Toal, Marie, additional, Weissinger, Florian, additional, and Schwartz, Stefan, additional

Published
2020
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40. Detection of Fusarium Species in Clinical Specimens by Probe-Based Real-Time PCR

Author

Springer, Jan, Walther, Grit, Rickerts, Volker, Hamprecht, Axel, Willinger, Birgit, Teschner, Daniel, Einsele, Hermann, Kurzai, Oliver, Loeffler, Juergen, Springer, Jan, Walther, Grit, Rickerts, Volker, Hamprecht, Axel, Willinger, Birgit, Teschner, Daniel, Einsele, Hermann, Kurzai, Oliver, and Loeffler, Juergen

Abstract

The mold Fusarium is a ubiquitous fungus causing plant, animal and human infections. In humans, Fusarium spp. are the major cause of eye infections in patients wearing contact lenses or after local trauma. Systemic infections by Fusarium spp. mainly occur in immunosuppressed patients and can disseminate throughout the human body. Due to high levels of resistance to antifungals a fast identification of the causative agent is an urgent need. By using a probe-based real-time PCR assay specific for the genus Fusarium we analysed several different clinical specimens detecting Fusarium spp. commonly found in clinical samples in Germany. Also, a large collection of lung fluid samples of haematological patients was analysed (n = 243). In these, two samples (0.8%) were reproducibly positive, but only one could be confirmed by sequencing. For this case of probable invasive fungal disease (IFD) culture was positive for Fusarium species. Here we describe a rapid, probe-based real-time PCR assay to specifically detect DNA from a broad range of Fusarium species and its application to clinically relevant specimens.

Published
2019

41. Impact of neutropenia on central venous catheter–related bloodstream infections in patients with hematological malignancies at the time of central venous catheter insertion: A matched-pair analysis

Author

Tölle, Daniela, primary, Hentrich, Marcus, additional, Pelzer, Benedikt W., additional, Kremer, Pierre, additional, Einhell, Sabine, additional, Schulz, Sebastian, additional, Böll, Boris, additional, Panse, Jens, additional, Schmidt-Hieber, Martin, additional, Teschner, Daniel, additional, and Schalk, Enrico, additional

Published
2019
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44. Coincident airway exposure to low-potency allergen and cytomegalovirus sensitizes for allergic airway disease by viral activation of migratory dendritic cells

Author

Reuter, Sebastian, primary, Lemmermann, Niels A. W., additional, Maxeiner, Joachim, additional, Podlech, Jürgen, additional, Beckert, Hendrik, additional, Freitag, Kirsten, additional, Teschner, Daniel, additional, Ries, Frederic, additional, Taube, Christian, additional, Buhl, Roland, additional, Reddehase, Matthias J., additional, and Holtappels, Rafaela, additional

Published
2019
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45. Clinical Validation of a Novel Elispot-Based Diagnostic Assay: Monitoring Cytomegalovirus-Specific Cell-Mediated Immunity and Risk Stratification in Hematopoietic Stem Cell Transplant Recipients

Author

Wagner, Eva, primary, Teschner, Daniel, additional, Wolschke, Christine, additional, Janson, Dietlinde, additional, Schaefer-Eckart, Kerstin, additional, Gaertner, Johannes, additional, Mielke, Stephan, additional, Schreder, Martin, additional, Kobbe, Guido, additional, Kondakci, Mustafa, additional, Klein, Stefan, additional, Heidenreich, Daniela, additional, Kreil, Sebastian, additional, Hilgendorf, Inken, additional, von Lilienfeld-Toal, Marie, additional, Verbeek, Mareike, additional, Grass, Sandra, additional, Ditschkowski, Markus, additional, Gromke, Tanja, additional, Koch, Martina, additional, Huenig, Thomas, additional, Lindemann, Monika, additional, Schmidt, Traudel, additional, Rascle, Anne, additional, Guldan, Harald, additional, Barabas, Sascha, additional, Deml, Ludwig, additional, Wagner, Ralf, additional, and Wolff, Daniel, additional

Published
2019
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48. 1575. Clinical Validation of a Novel ELISpot-based in vitro Diagnostic Assay to Monitor CMV-Specific Cell-Mediated Immunity in SOT and HSCT Immunocompromised Patients

Author

Banas, Bernhard, primary, Steubl, Dominik, additional, Renders, Lutz, additional, Chittka, Dominik, additional, Banas, Miriam, additional, Wekerle, Thomas, additional, Koch, Martina, additional, Witzke, Oliver, additional, Lindemann, Monika, additional, Muehlfeld, Anja, additional, Sommerer, Claudia, additional, Habicht, Antja, additional, Hugo, Christian, additional, Huenig, Thomas, additional, Mielke, Stephan, additional, Schreder, Martin, additional, Wagner, Eva, additional, Teschner, Daniel, additional, Klein, Stefan, additional, Heidenreich, Daniela, additional, Kreil, Sebastian, additional, Schaefer-Eckart, Kerstin, additional, Gaertner, Johannes, additional, Verbeek, Mareike, additional, Grass, Sandra, additional, Wolschke, Christine, additional, Janson, Dietlinde, additional, Kobbe, Guido, additional, Kondakci, Mustafa, additional, Ditschkowski, Markus, additional, Gromke, Tanja, additional, Hilgendorf, Inken, additional, Lilienfeld-Toal, Marie Von, additional, Schmidt, Traudel, additional, Rascle, Anne, additional, Barabas, Sascha, additional, Deml, Ludwig, additional, Wagner, Ralf, additional, Kraemer, Bernhard, additional, Krueger, Bernd, additional, and Wolff, Daniel, additional

Published
2018
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49. Primary prophylaxis of invasive fungal infections in patients with haematological malignancies: 2017 update of the recommendations of the Infectious Diseases Working Party (AGIHO) of the German Society for Haematology and Medical Oncology (DGHO)

Author

Mellinghoff, Sibylle C., Panse, Jens, Alakel, Nael, Behre, Gerhard, Buchheidt, Dieter, Christopeit, Maximilian, Hasenkamp, Justin, Kiehl, Michael, Koldehoff, Michael, Krause, Stefan W., Lehners, Nicola, von Lilienfeld-Toal, Marie, Loehnert, Annika Y., Maschmeyer, Georg, Teschner, Daniel, Ullmann, Andrew J., Penack, Olaf, Ruhnke, Markus, Mayer, Karin, Ostermann, Helmut, Wolf, Hans-H., Cornely, Oliver A., Mellinghoff, Sibylle C., Panse, Jens, Alakel, Nael, Behre, Gerhard, Buchheidt, Dieter, Christopeit, Maximilian, Hasenkamp, Justin, Kiehl, Michael, Koldehoff, Michael, Krause, Stefan W., Lehners, Nicola, von Lilienfeld-Toal, Marie, Loehnert, Annika Y., Maschmeyer, Georg, Teschner, Daniel, Ullmann, Andrew J., Penack, Olaf, Ruhnke, Markus, Mayer, Karin, Ostermann, Helmut, Wolf, Hans-H., and Cornely, Oliver A.

Abstract

Immunocompromised patients are at high risk of invasive fungal infections (IFI), in particular those with haematological malignancies undergoing remission-induction chemotherapy for acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) and recipients of allogeneic haematopoietic stem cell transplants (HSCT). Despite the development of new treatment options in the past decades, IFI remains a concern due to substantial morbidity and mortality in these patient populations. In addition, the increasing use of new immune modulating drugs in cancer therapy has opened an entirely new spectrum of at risk periods. Since the last edition of antifungal prophylaxis recommendations of the German Society for Haematology and Medical Oncology in 2014, seven clinical trials regarding antifungal prophylaxis in patients with haematological malignancies have been published, comprising 1227 patients. This update assesses the impact of this additional evidence and effective revisions. Our key recommendations are the following: prophylaxis should be performed with posaconazole delayed release tablets during remission induction chemotherapy for AML and MDS (AI). Posaconazole iv can be used when the oral route is contraindicated or not feasible. Intravenous liposomal amphotericin B did not significantly decrease IFI rates in acute lymphoblastic leukaemia (ALL) patients during induction chemotherapy, and there is poor evidence to recommend it for prophylaxis in these patients (CI). Despite substantial risk of IFI, we cannot provide a stronger recommendation for these patients. There is poor evidence regarding voriconazole prophylaxis in patients with neutropenia (CII). Therapeutic drug monitoring TDM should be performed within 2 to 5 days of initiating voriconazole prophylaxis and should be repeated in case of suspicious adverse events or of dose changes of interacting drugs (BIItu). General TDM during posaconazole prophylaxis is not recommended (CIItu), but may be helpful in cases

Published
2018

50. A Comparison of Aspergillus and Mucorales PCR Testing of Different Bronchoalveolar Lavage Fluid Fractions from Patients with Suspected Invasive Pulmonary Fungal Disease

Author

Springer, Jan, White, P. Lewis, Kessel, Johanna, Wieters, Imke, Teschner, Daniel, Korczynski, Daniel, Liebregts, Tobias, Cornely, Oliver A., Schwartz, Stefan, Elgeti, Thomas, Meintker, Lisa, Krause, Stefan W., Posso, Raquel B., Heinz, Werner J., Fuhrmann, Sandra, Vehreschild, Joerg Janne, Einsele, Hermann, Rickerts, Volker, Loeffler, Juergen, Springer, Jan, White, P. Lewis, Kessel, Johanna, Wieters, Imke, Teschner, Daniel, Korczynski, Daniel, Liebregts, Tobias, Cornely, Oliver A., Schwartz, Stefan, Elgeti, Thomas, Meintker, Lisa, Krause, Stefan W., Posso, Raquel B., Heinz, Werner J., Fuhrmann, Sandra, Vehreschild, Joerg Janne, Einsele, Hermann, Rickerts, Volker, and Loeffler, Juergen

Abstract

In patients with hematological malignancies, bronchoalveolar lavage fluid (BALF) specimens are commonly used for the diagnosis of mold infections. However, it is not clear whether the cell pellet (P) or the supernatant fraction (S) of the BALF specimen is optimal for molecular diagnostic testing. Thus, 99 BALF specimens were collected from 96 hematology patients with or without allogeneic hematopoietic stem cell transplant. The cell pellets and supernatants were processed alone and in combination (S/P) for testing by two fungus-specific real-time PCR assays compliant with international recommendations. The results achieved with S/P were revealed to be superior in comparison to those achieved with S and P alone, with the use of each single fraction showing a reduced sensitivity for the detection of Aspergillus DNA (82% and 43% for S and P, respectively). In 57% of the samples, testing of the combination of S and P generated a lower quantification cycle value than testing of S or P alone. Molds would have been missed in 5 and 16 out of 28 samples if only S or P, respectively, was analyzed. No sample was positive by testing of S or P only. Similar results were obtained for the detection of Mucorales DNA in BALF specimens (reduced sensitivity of 67% and 50% for S and P, respectively). Study patients were categorized according to the current European Organization for the Research and Treatment of Cancer/Mycoses Study Group classification for invasive fungal disease (IFD), revealing that 35 patients had proven/probable IFD (36%), 47 patients had possible IFD (49%), and 14 patients had undetermined IFD (15%).

Published
2018

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