CompletedNot Applicable

Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients

Germany792 participantsStarted 2017-12-21

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Patients unwilling/ineligible for vaccination under current STIKO recommendations

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison of pneumonia rates between newly vaccinated hemodialysis patients and those vaccinated against pneumococcal infection more than 2 years ago

Timeframe: 2 years

Trial details

NCT IDNCT03350425

SponsorUniversity of Cologne

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-01

View on ClinicalTrials.gov More CKD (Chronic Kidney Disease) Stage 5D trials