Z94
Conditions
Interventions
Group 1: Patients with previous autologous or allogeneic hematopoietic stem cell transplantation (HSCT) with infectious or unclear CNS disorder
Group 2: Patients with previous autologous or allogeneic
Sponsors
Medizinische Universität Lausitz- Carl Thiem
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with previous autologous or allogeneic HSCT and no more than 5 days of onset of infectious or unclear CNS disorder after HSCT 2. Patients with previous autologous or allogeneic HSCT and without CNS dysfunction after HSCT (HSCT control group) 3. Healthy subjects with vs. without previous SARS-CoV-2 infection (control group confirmed by SARS-CoV-2 PCR in patients with previous SARS-CoV-2 infection) -Healthy subjects qualify here are persons who do not have severe disease such as tumor disease (except for full remission for >2 years) or higher grade (CTCAE V.5 >2°) organ insufficiencies such as heart failure or renal failure. However, for example, patients with controlled hypertension or hyperlipidemia may be included as healthy subjects if the other inclusion and exclusion criteria are met 4. Presence of a written declaration of consent
Exclusion criteria
Exclusion criteria: 1. Lack of informed consent or capacity to consent on the part of the patient/subject (unless legal guardianship or power of attorney for health care is present) 2. Increasing somnolence with significantly reduced life expectancy (<1 month according to the investigator's assessment) 3. Apparent known side effect of centrally acting substances (e.g., sedation with benzodiazepines or opiod-based pain therapy in patients with an inaustere prognosis in the terminal phase) 4. Unclear CNS dysfunction in the setting of multiorgan failure in the terminal phase 5. Apparent noninfectious CNS disorder (such as cerebral hemorrhage, meningioma neoplastica) when there is no evidence of concomitant infectious or other unclear CNS disorder 6. Very mild unexplained CNS disorder (CTCAE 0-1°)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. detection of pathogens in blood and CSF by NGS compared to conventional microbiological methods in patients with CNS infection or unclear CNS disorder after HSCT compared to patients after HSCT without subsequent CNS disorder 2. studies on biomarkers such as antineuronal antibodies, anti-SARS-CoV-2 antibodies, SARS-CoV-2-specific T cells in blood and CSF in patients with vs. without infectious or unclear CNS disorder after HSCT in comparison to healthy subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. comparison of lymphocyte subpopulations and other biomarkers in blood and CSF in healthy subjects with or without previous SARS-CoV-2 infection as a reference population for the cohort of patients after HSCT 2. describe characteristics of different forms of CNS infections in patients after HSCT (e.g., patterns in CNS imaging, CSF characteristics) incorporating NGS-based vs. conventional pathogen diagnostics 3. description of characteristics of different forms of CNS infections in patients after HSCT (e.g. patterns in CNS imaging, CSF characteristics) including NGS-based vs. conventional pathogen diagnostics | — |
Countries
Germany
Contacts
Public ContactMartin Schmidt-Hieber
Medizinische Universität Lausitz- Carl Thiem
Outcome results
None listed