Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients (DOPPIO): Protocol for a Prospective Multicenter Study.

Autor:	Mellinghoff S; Centre for Integrated Oncology Aachen Bonn Cologne Duesseldorf and Excellence Centre for Medical Mycology, Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.; German Centre for Infection Research, Partner Site Bonn-Cologne, Cologne, Germany.; Faculty of Medicine and University Hospital Cologne, Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases, University of Cologne, Cologne, Germany., von Gersdorff G; Faculty of Medicine and University Hospital Cologne, Department II of Internal Medicine - QiN-group, University of Cologne, Cologne, Germany.; Kuratorium fuer Haemaodialyse (KfH)-Board of Trustees for Dialysis and Kidney Transplantation, Neu-Isenburg, Germany., Bruns C; Centre for Integrated Oncology Aachen Bonn Cologne Duesseldorf and Excellence Centre for Medical Mycology, Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.; German Centre for Infection Research, Partner Site Bonn-Cologne, Cologne, Germany.; Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany., Albus K; Centre for Integrated Oncology Aachen Bonn Cologne Duesseldorf and Excellence Centre for Medical Mycology, Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.; German Centre for Infection Research, Partner Site Bonn-Cologne, Cologne, Germany.; Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany., Dimitriou V; Centre for Integrated Oncology Aachen Bonn Cologne Duesseldorf and Excellence Centre for Medical Mycology, Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.; German Centre for Infection Research, Partner Site Bonn-Cologne, Cologne, Germany.; Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany., Steinbach A; Centre for Integrated Oncology Aachen Bonn Cologne Duesseldorf and Excellence Centre for Medical Mycology, Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.; German Centre for Infection Research, Partner Site Bonn-Cologne, Cologne, Germany.; Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany., Schaller M; Faculty of Medicine and University Hospital Cologne, Department II of Internal Medicine - QiN-group, University of Cologne, Cologne, Germany., Vehreschild JJ; Centre for Integrated Oncology Aachen Bonn Cologne Duesseldorf and Excellence Centre for Medical Mycology, Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany., Cornely OA; Centre for Integrated Oncology Aachen Bonn Cologne Duesseldorf and Excellence Centre for Medical Mycology, Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.; German Centre for Infection Research, Partner Site Bonn-Cologne, Cologne, Germany.; Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.; Clinical Trials Centre Cologne (ZKS Köln), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany., Liss BJ; Department I of Internal Medicine, Helios University Hospital Wuppertal, Wuppertal, Germany.; School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.
Jazyk:	angličtina
Zdroj:	JMIR research protocols [JMIR Res Protoc] 2023 Jul 12; Vol. 12, pp. e45712. Date of Electronic Publication: 2023 Jul 12.
DOI:	10.2196/45712
Abstrakt:	Background: Pneumonia is a leading cause of death in patients with end-stage chronic kidney disease treated with dialysis. Current vaccination schedules recommend pneumococcal vaccination. However, this schedule disregards findings of rapid titer decline in adult hemodialysis patients after 12 months. Objective: The primary objective is to compare pneumonia rates between recently vaccinated patients and patients vaccinated more than 2 years ago. As an exploratory objective, antipneumococcal antibody titers in hemodialysis patients will be determined as a function. Factors influencing antibody kinetics will be identified. Methods: Within this prospective multicenter study, we aim to compare 2 strata of vaccinated patients: those recently vaccinated and those vaccinated more than 2 years ago. A total of 792 patients will be enrolled. Twelve partner sites (within the German Centre for Infection Research [DZIF]) with allocated dialysis practices participate in this study. All dialysis patients who are vaccinated against pneumococcal infection in accordance with Robert Koch Institute guidelines prior to enrollment will be eligible. Data on baseline demographics, vaccination history, and underlying disease will be assessed. Pneumococcal antibody titers will be determined at baseline and every 3 months for 2 years. DZIF clinical trial units coordinate titer assessment schedules and actively follow-up on study patients for 2-5 years after enrollment, including validation of end points of hospitalization, pneumonia, and death. Results: The study has enrolled 792 patients and the last follow-up has been completed. Currently, the statistical and laboratory analyses are ongoing. Conclusions: Results will increase physician adherence to current recommendations. Establishing a framework for the efficient evaluation of guideline recommendations through a combination of routine and study data will inform the evidence base for future guidelines. Trial Registration: ClinicalTrials.gov NCT03350425; https://clinicaltrials.gov/ct2/show/NCT03350425. International Registered Report Identifier (irrid): DERR1-10.2196/45712. (©Sibylle Mellinghoff, Gero von Gersdorff, Caroline Bruns, Kerstin Albus, Vassiliki Dimitriou, Angela Steinbach, Mathias Schaller, Jörg Janne Vehreschild, Oliver A Cornely, Blasius Janusch Liss. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 12.07.2023.)
Databáze:	MEDLINE
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