CKD (Chronic Kidney Disease) Stage 5DDOPPIONCT03350425
Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients
An observational study of CKD (Chronic Kidney Disease) Stage 5D and Pneumonia, run by University of Cologne at 12 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD (Chronic Kidney Disease) Stage 5D, Pneumonia
- Type of treatment
- Vaccines
- How many people
- 792 participants
- Where
- 12 sitesGermany
- Study dates
- 21 Dec 2017to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult hemodialysis patients vaccinated against pneumococcal infection or eligible and willing to be vaccinated
Who may be able to join
- Signed informed consent form including enrolment in registry database (QiN-registry)
- Patients with stage 5 chronic kidney disease treated with chronic hemodialysis
- Patients who are either already vaccinated or eligible and willing to be vaccinated against pneumococcal infection in accordance with current STIKO recommendations
- Age of 18 years or older
Who cannot join
- Patients unwilling/ineligible for vaccination under current STIKO recommendations
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
Medical Clinic, Research Center Borstel
Borstel, Schleswig-Holstein, 23845
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
University Hospital Giessen und Marburg, Giessen site
Giessen, Hesse, 35392
University Hospital Hamburg-Eppendorf
Hamburg, 20246
Hannover Medical School
Hanover, Lower Saxony, 30625
University Hospital Heidelberg
Heidelberg, Hesse, 69120
University Hospital Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, 23562
University Hospital Giessen und Marburg, Marburg site
Marburg, Hesse, 35043
Hospital of the Ludwig-Maximilians-University (LMU)
Munich, Bavaria, 80336
The University Hospital Klinikum rechts der Isar - MRI TUM
Munich, Bavaria, 81675
Eberhard Karls University Tübingen
Tübingen, Baden-Wurttemberg, 72074
About this study
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.
Read the detailed description
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).
- Conditions
- CKD (Chronic Kidney Disease) Stage 5D, Pneumonia
- Keywords
- hemodialysis, pneumococcal vaccination
- Medical subject headings
- Renal Insufficiency, Chronic, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recently vaccinated patients | Patients who recently received pneumococcal vaccination. | |
| Patients vaccinated >2 years ago | Patients who received pneumococcal vaccination more than two years ago. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pneumonia rates between newly vaccinated hemodialysis patients and those vaccinated against pneumococcal infection more than 2 years ago
Measured: 2 years
Secondary outcomes (2)
Pneumococcal antibody kinetics as a function of time since vaccination.
Description of antibody titers in hemodialysis patients as a function of time since vaccination.
Measured: 2 years
Factors influencing antibody kinetics
Determination of factors influencing antibody kinetics (e.g. age, prior or ongoing immunosuppression, medication, prior vaccination history) by multiple multivariate models
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start21 Dec 2017
- Primary completion1 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CKD (Chronic Kidney Disease) Stage 5DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 792 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Infection Research
- Responsible party
- Principal investigator, Oliver Cornely, MD, University of Cologne
- Investigators
- Oliver A Cornely, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350425
- Sponsor's protocol ID
- DOPPIO
- Acronym
- DOPPIO
- Status last verified
- Dec 2024
- First submitted
- 6 Jun 2017
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37436797
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03350425
- Acronym / sponsor ID
- DOPPIO / DOPPIO
- Conditions
- CKD (Chronic Kidney Disease) Stage 5D, Pneumonia
- Keywords
- hemodialysis, pneumococcal vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- German Center for Infection Research
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recently vaccinated patients | – | –Patients who recently received pneumococcal vaccination. |
| Patients vaccinated >2 years ago | – | –Patients who received pneumococcal vaccination more than two years ago. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult hemodialysis patients vaccinated against pneumococcal infection or eligible and willing to be vaccinated
Key inclusion criteria (4 listed)
- Signed informed consent form including enrolment in registry database (QiN-registry)
- Patients with stage 5 chronic kidney disease treated with chronic hemodialysis
- Patients who are either already vaccinated or eligible and willing to be vaccinated against pneumococcal infection in accordance with current STIKO recommendations
- Age of 18 years or older
Key exclusion criteria (1 listed)
- Patients unwilling/ineligible for vaccination under current STIKO recommendations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of pneumonia rates between newly vaccinated hemodialysis patients and those vaccinated against pneumococcal infection more than 2 years ago
Time frame: 2 years
2 secondary outcomes
Pneumococcal antibody kinetics as a function of time since vaccination.
Time frame: 2 years
Factors influencing antibody kinetics
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 37436797Mellinghoff 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver A Cornely, MD principal investigator
University of Cologne
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD (Chronic Kidney Disease) Stage 5D and Pneumonia, run by University of Cologne at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pneumonia rates between newly vaccinated hemodialysis patients and those vaccinated against pneumococcal infection more than 2 years ago (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03350425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.