SaDial: the adaptive immune response against Staphylococcus aureus in hemoDialysis patients
Not Applicable
Completed
- Conditions
- Staphylococcus aureus bloodstream infection and S. aureus carrier status in hemodialysis patientsInfections and Infestations
- Registration Number
- ISRCTN14385893
- Lead Sponsor
- Damp Stiftung
- Brief Summary
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31060511 (added 08/05/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 86
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
1. Refusal to participate
2. Moving to another town that is not Greifswald
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Overall mortality rates, assessed using Kaplan-Meier analysis after the final sampling<br> 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<br>
- Secondary Outcome Measures
Name Time Method <br> 1. S. aureus genotype profiles over time, assessed after each 6 month sampling:<br> 1.1. S. aureus spa-types determined by spa-PCR and out coming sequences classified by Ridom software<br> 1.2. Clonal complexes (CC types) of S. aureus determined using S. aureus Genotyping Kit 2.0 from Alere Technologies (now Abbott)<br> 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<br> 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<br><br>