SaDial: the adaptive immune response against Staphylococcus aureus in hemoDialysis patients

Mortality and bloodstream infections in hemodialysis patients from an outpatient dialysis center (KfH e.V.) in Greifswald with respect to S. aureus carrier status, colonization density, S. aureus genotyping and host immune response (SaDial-study) compared to the general population of the same geographical region (SHIP-TREND-0)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN14385893

Enrollment

106

Registered

2018-10-02

Start date

2015-06-18

Completion date

Unknown

Last updated

2019-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Staphylococcus aureus bloodstream infection and S. aureus carrier status in hemodialysis patients Infections and Infestations Staphylococcus aureus bloodstream infection and S. aureus carrier status in hemodialysis patients

Interventions

A cohort of 86 hemodialysis patients are followed over a 30 month period. Patient demographic data and medical history are collected, followed and statistically evaluated. Blood samples, nasal swabs a

however, swabs and blood and serum samples are only take once in 2015 for this group. There is no follow-up period.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients: 1. Hemodialysis patients of an outpatient dialysis centre (KfH e.V.) in Greifswald 2. Voluntary participation Controls: 1. Voluntary participation 2. Aged 50-70 3. Renally healthy 4. In hospital for at least 1 week

Exclusion criteria

Exclusion criteria: 1. Refusal to participate 2. Moving to another town that is not Greifswald

Design outcomes

Primary

Measure	Time frame
1. Overall mortality rates, assessed using Kaplan-Meier analysis after the final sampling 2. Course and severity of bloodstream infection, determined by assessing for symptoms such as leukocytosis, fever and systemic inflammatory response syndrome, and a positive test for S. aureus in blood culture. This was assessed at the time of infection, and 7 and 14 days after	—

Secondary

Measure	Time frame
1. S. aureus genotype profiles over time, assessed after each 6 month sampling: 1.1. S. aureus spa-types determined by spa-PCR and out coming sequences classified by Ridom software 1.2. Clonal complexes (CC types) of S. aureus determined using S. aureus Genotyping Kit 2.0 from Alere Technologies (now Abbott) 2. S. aureus specific antibody response over time assessed using a multiplex assay and ELISA, with antibodies isolated every 6 months and stored and overall measurement taken once all samples are collected 3. T-cell response over time, assessed by a Fluorospot assay, with T-cells isolated every 6 months and stored and overall measurement taken once all samples are collected	—

Measure

Time frame

1. S. aureus genotype profiles over time, assessed after each 6 month sampling: 1.1. S. aureus spa-types determined by spa-PCR and out coming sequences classified by Ridom software 1.2. Clonal complexes (CC types) of S. aureus determined using S. aureus Genotyping Kit 2.0 from Alere Technologies (now Abbott) 2. S. aureus specific antibody response over time assessed using a multiplex assay and ELISA, with antibodies isolated every 6 months and stored and overall measurement taken once all samples are collected 3. T-cell response over time, assessed by a Fluorospot assay, with T-cells isolated every 6 months and stored and overall measurement taken once all samples are collected

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026