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| Name | Class |
|---|---|
| German Center for Infection Research | OTHER |
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The investigators compare two strata of vaccinated patients: those recently vaccinated and those vaccinated more than two years ago. The primary objective is to compare pneumonia rates between the groups. As exploratory objectives, the investigators will describe the anti-pneumococcal antibody titers in hemodialysis patients as a function of time since vaccination, and determine factors influencing antibody kinetics. Further exploratory objectives investigate the relationship between antibody titers and the incidence of pneumonia in hemodialysis patients and extrapolate a possible cut-off for protection from pneumonia.
Participating sites will screen all hemodialysis patients at their outpatient dialysis clinic for eligibility. Eligible patients will be approached and informed by their treating physician. If a patient agrees to participate in the study and to sign an informed consent form, basic data regarding vaccination history, underlying disease, etc. will be entered or electronically imported into the study eCRF. Pneumococcal antibody titers will be drawn at baseline and every 3 months. For newly vaccinated patients baseline titers will be drawn 4 weeks after the vaccination. DZIF CTUs will coordinate titer assessment schedules and inform the participating physicians of upcoming blood samplings. The samples will be taken on dialysis days and thus constitute only a minimal additional burden for both patients and physicians. DZIF CTUs will actively follow up on study patients for 2 years after enrolment. This follow-up will include validation of all hospitalizations and deaths documented in an electronic registry database to assess whether the primary endpoint (pneumonia) occurred. Additionally, dialysis units will be contacted every 6 months to assess if pneumonia occurred, which did not require hospitalization. DZIF CTUs will document titer assessment results in the eCRF. Titers will not be disclosed to the attending physicians because revaccination due to knowledge of titers would produce bias. All therapies and diagnostics including vaccinations will be administered solely as part of clinical routine and as recommended by appropriate guidelines (e.g. RKI STIKO recommendations).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recently vaccinated patients | Patients who recently received pneumococcal vaccination. | ||
| Patients vaccinated >2 years ago | Patients who received pneumococcal vaccination more than two years ago. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of pneumonia rates between newly vaccinated hemodialysis patients and those vaccinated against pneumococcal infection more than 2 years ago | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumococcal antibody kinetics as a function of time since vaccination. | Description of antibody titers in hemodialysis patients as a function of time since vaccination. | 2 years |
| Factors influencing antibody kinetics |
| Measure | Description | Time Frame |
|---|---|---|
| Exploration of the relationship between anti-pneumococcal antibody titers and a possible cut-off for protection from pneumonia | Exploration of the relationship between anti-pneumococcal antibody titers and the incidence of pneumonia in hemodialysis patients and extrapolation of a possible cut-off for protection from pneumonia. | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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Adult hemodialysis patients vaccinated against pneumococcal infection or eligible and willing to be vaccinated
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| Name | Affiliation | Role |
|---|---|---|
| Oliver A Cornely, MD | University of Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eberhard Karls University Tübingen | Tübingen | Baden-Wurttemberg | 72074 | Germany | ||
| Hospital of the Ludwig-Maximilians-University (LMU) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37436797 | Derived | Mellinghoff S, von Gersdorff G, Bruns C, Albus K, Dimitriou V, Steinbach A, Schaller M, Vehreschild JJ, Cornely OA, Liss BJ. Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients (DOPPIO): Protocol for a Prospective Multicenter Study. JMIR Res Protoc. 2023 Jul 12;12:e45712. doi: 10.2196/45712. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Blood samples will be obtained for determination of pneumococcal antibody-titers every three months for two years. The samples will be taken on dialysis days and thus constitute only a minimal additional burden for both patients and physicians
Determination of factors influencing antibody kinetics (e.g. age, prior or ongoing immunosuppression, medication, prior vaccination history) by multiple multivariate models
| 2 years |
| Factors influencing pneumonia and vaccine response |
Evaluation of role of patient history (e.g. underlying kidney disease) and clinical course (e.g. prior hospitalizations) on pneumonia and vaccine response. |
| 2 years |
| Munich |
| Bavaria |
| 80336 |
| Germany |
| The University Hospital Klinikum rechts der Isar - MRI TUM | Munich | Bavaria | 81675 | Germany |
| University Hospital Giessen und Marburg, Giessen site | Giessen | Hesse | 35392 | Germany |
| University Hospital Heidelberg | Heidelberg | Hesse | 69120 | Germany |
| University Hospital Giessen und Marburg, Marburg site | Marburg | Hesse | 35043 | Germany |
| Hannover Medical School | Hanover | Lower Saxony | 30625 | Germany |
| University Hospital Bonn | Bonn | North Rhine-Westphalia | 53127 | Germany |
| University Hospital Cologne | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Medical Clinic, Research Center Borstel | Borstel | Schleswig-Holstein | 23845 | Germany |
| University Hospital Schleswig-Holstein, Campus Lübeck | Lübeck | Schleswig-Holstein | 23562 | Germany |
| University Hospital Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |