Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Mellinghoff S

PROVIDER: S-EPMC10372763 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Mellinghoff Sibylle S von Gersdorff Gero G Bruns Caroline C Albus Kerstin K Dimitriou Vassiliki V Steinbach Angela A Schaller Mathias M Vehreschild Jörg Janne JJ Cornely Oliver A OA Liss Blasius Janusch BJ

JMIR research protocols 20230712

<h4>Background</h4>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.<h4>Objective</h4>The primary objective is to compare pneumonia rates between recently vaccinated patients and patients vaccinated more than 2 years ago. As an exploratory objective, antipneu ...[more]

PMID: 37436797

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Project description:BackgroundPneumonia and pneumococcal disease cause a large disease burden in resource-constrained settings. We pursue an extended cost-effectiveness analysis (ECEA) of two fully publicly financed interventions in Ethiopia: pneumococcal vaccination for newborns and pneumonia treatment for under-five children in Ethiopia.MethodsWe apply ECEA methods and estimate the program impact on: (1) government program costs; (2) pneumonia and pneumococcal deaths averted; (3) household expenses related to pneumonia/pneumococcal disease treatment averted; (4) prevention of household medical impoverishment measured by an imputed money-metric value of financial risk protection; and (5) distributional consequences across the wealth strata of the country population. Available epidemiological and cost data from Ethiopia are applied and the two interventions are assessed separately at various incremental coverage levels.ResultsScaling-up pneumococcal vaccines at around 40% coverage would cost about $11.5 million and avert about 2090 child deaths annually, while a 10% increase of pneumonia treatment to all children under 5 years of age would cost about $13.9 million and avert 2610 deaths annually. Health benefits of the two interventions publicly financed would be concentrated among the bottom income quintile, where 30-40% of all deaths averted would be expected to occur in the poorest quintile. In sum, the two interventions would eliminate a total of $2.4 million of private household expenditures annually, where the richest quintile benefits from around 30% of the total private expenditures averted. The financial risk protection benefits would be largely concentrated among the bottom income quintile. The results are most sensitive to variations in vaccine price, population size, number of deaths due to pneumonia, efficacy of interventions and out-of-pocket copayment share.ConclusionsVaccine and treatment interventions for children, as shown with the illustrative examples of pneumococcal vaccine and pneumonia treatment, can bring large health and financial benefits to households in Ethiopia, most particularly among the poorest socio-economic groups.

Project description:Background"Interstitial lung disease" (ILD) is a broad term encompassing diseases of different backgrounds. "Interstitial pneumonia with autoimmune features" (IPAF) is a recent term that implies the presence of autoimmunity.ObjectiveThis study aims to determine the characteristics of Polish patients with IPAF, compare them with patients with other interstitial pneumonias, and search for the prognostic and diagnostic biomarkers of IPAF in serum and bronchoalveolar lavage fluid (BALF).MethodsThis multicenter prospective study plans to recruit 240 participants divided into 1 study group and 2 control groups. Biological fluid samples will be collected according to Polish Respiratory Society management guidelines and stored at -80°C for further tests. Prospective 5-year observations of 60 newly diagnosed individuals are planned. The study will be divided into subsections. First, we plan to characterize Polish patients with IPAF (study group) against their peers with other ILDs (2 control groups). Control group 1 will comprise patients with idiopathic ILDs, including mainly idiopathic pulmonary fibrosis and nonspecific interstitial pneumonia. Control group 2 will comprise patients with connective tissue disease-associated interstitial lung diseases, such as rheumatoid arthritis, systemic sclerosis, polymyositis, dermatomyositis, Sjögren's syndrome, mixed connective tissue disease, and systemic lupus erythematosus. Radiological and functional parameters will be analyzed. Patients will be compared in terms of high-resolution computed tomography results, the 6-minute walking test performance, and pulmonary function test parameters. The diagnosis of IPAF will be reassessed on a regular basis through multidisciplinary discussion in order to determine its clinical stability. In the laboratory arm, inflammation and fibrosis pathways will be assessed. Cytokine levels (interleukin 8, transforming growth factor beta 1, chemokine C-C motif ligand [CXCL]18, CXCL1, surfactant protein [SP]-A, SP-D, Krebs von den Lungen-6 protein, and chitinase 1) will be measured in serum and BALF. A comparative analysis of serum and BALF cytokine levels will be performed in order to establish potential differences between systemic and local inflammatory pathways. In the quality of life (QoL) arm of the study, dyspnea and cough and their impact on various aspects of the QoL will be assessed. Depression and anxiety will be measured with the Hospital Anxiety and Depression Modified Scale and the 9-item Patient Health Questionnaire, and potential correlations with symptom prevalence will be assessed.ResultsThis study will start recruiting patients to phase 1 in October 2023. The final results will be available in 2028. We plan to publish preliminary results after 2-3 years from the start of phase 1.ConclusionsThis study will be a step toward a better understanding of IPAF etiopathogenesis and outcomes.International registered report identifier (irrid)PRR1-10.2196/44802.

Project description:Streptococcus pneumoniae (Sp) frequently causes secondary pneumonia after influenza A virus (IAV) infection, leading to high morbidity and mortality worldwide. Concomitant pneumococcal and influenza vaccination improves protection against coinfection but does not always yield complete protection. Impaired innate and adaptive immune responses have been associated with attenuated bacterial clearance in influenza virus-infected hosts. In this study, we showed that preceding low-dose IAV infection caused persistent Sp infection and suppression of bacteria-specific T-helper type 17 (Th17) responses in mice. Prior Sp infection protected against subsequent IAV/Sp coinfection by improving bacterial clearance and rescuing bacteria-specific Th17 responses in the lungs. Furthermore, blockade of IL-17A by anti-IL-17A antibodies abrogated the protective effect of Sp preinfection. Importantly, memory Th17 responses induced by Sp preinfection overcame viral-driven Th17 inhibition and provided cross-protection against different Sp serotypes following coinfection with IAV. These results indicate that bacteria-specific Th17 memory cells play a key role in providing protection against IAV/Sp coinfection in a serotype-independent manner and suggest that a Th17-based vaccine would have excellent potential to mitigate disease caused by coinfection. IMPORTANCE Streptococcus pneumoniae (Sp) frequently causes secondary bacterial pneumonia after influenza A virus (IAV) infection, leading to increased morbidity and mortality worldwide. Current pneumococcal vaccines induce highly strain-specific antibody responses and provide limited protection against IAV/Sp coinfection. Th17 responses are broadly protective against Sp single infection, but whether the Th17 response, which is dramatically impaired by IAV infection in naïve mice, might be effective in immunization-induced protection against pneumonia caused by coinfection is not known. In this study, we have revealed that Sp-specific memory Th17 cells rescue IAV-driven inhibition and provide cross-protection against subsequent lethal coinfection with IAV and different Sp serotypes. These results indicate that a Th17-based vaccine would have excellent potential to mitigate disease caused by IAV/Sp coinfection.

Project description:BACKGROUND:Nonadherence to dietary and fluid restrictions, hemodialysis (HD), and medication treatment has been shown to increase the risks of hospitalization and mortality significantly. Sociodemographic and biochemical parameters as well as psychosocial conditions such as depression and anxiety are known to affect nonadherence in HD patients. However, evidence related to the relative importance and actual impact of these factors varies among studies. PURPOSE:The aim of this study was to identify the factors that affect nonadherence to dietary and fluid restrictions, HD, and medication treatment. METHODS:This descriptive study was conducted on 274 patients who were being treated at four HD centers in Turkey. The parameters used to determine nonadherence to dialysis treatment were as follows: skipping multiple dialysis sessions during the most recent 1-month period, shortening a dialysis session by more than 10 minutes during the most recent 1-month period, and Kt/V < 1.4. The parameters used to determine nonadherence to dietary and fluid restriction were as follows: serum phosphorus level > 7.5 mg/dl, predialysis serum potassium level > 6.0 mEq/L, and interdialytic weight gain > 5.7% of body weight. The Morisky Green Levine Medication Adherence Scale was performed to determine nonadherence to medication treatment. A patient was classified as nonadherent if he or she did not adhere to one or more of these indices. The Hospital Anxiety and Depression Scale was used to identify patient risk in terms of anxiety and depression. Logistic regression was used to determine the predictors of nonadherence. RESULTS:The nonadherence rate was 39.1% for dietary and fluid restrictions, 33.6% for HD, and 20.1% for medication. The risk of nonadherence to dietary and fluid restriction was found to be 4.337 times higher in high school graduates (95% CI [1.502, 12.754], p = .007). The risk of nonadherence to HD treatment was 2.074 times higher in men (95% CI [1.213, 3.546], p = .008) and 2.591 times higher in patients with a central venous catheter (95% CI [1.171, 5.733], p = .019). Longer duration in HD resulted in 0.992 times decrease in risk of nonadherence to treatment (95% CI [0.986, 0.998], p = .005). CONCLUSIONS/IMPLICATIONS FOR PRACTICE:Educational status, being male, having a central venous catheter, and having a short HD duration were found to be risk factors for nonadherence. Nurses must consider the patient's adherence to the dietary and fluid restrictions, HD, and medication treatment at each visit.

Dataset Information

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

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

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

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