Molecular pathogen diagnostics and studies of SARS-CoV-2 in patients with CNS disorder after hematopoietic stem cell transplantation and healthy subjects

• Conditions: Z94; Transplanted organ and tissue status

• Registration Number: DRKS00029343
• Lead Sponsor: Medizinische Universität Lausitz- Carl Thiem

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 140

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

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°)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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 Outcome Measures

Name	Time	Method
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<br>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 <br>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