ext-Generation Sequencing diagnostics of bacteremia in Pediatric Sepsis

Conditions: R65.1
Systemic Inflammatory Response Syndrome of infectious origin with organ failure

Registration Number: DRKS00015705

Lead Sponsor: Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 150

Inclusion Criteria

Age = 28 days and <6 years
- Informed consent by parent(s) or legal guardian

Severe Sepsis (with an onset =24h):
- Infants and toddlers with severe sepsis can be identified with a clinical construct of sepsis (Infection + = 2 criteria of a systemic inflammatory syndrome (SIRS)) together with clinical signs of an organ failure.

or Septic shock (with an onset =24h):
- Infants and toddlers with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP = 40 mmHg+1,5mmHg x age [years]) despite adequate volume resuscitation

Exclusion Criteria

Not provided

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For the evaluation of NGS-performance (sensitivity, specificity, positive predictive value, negative predictive value), results of the NGS-based approach for each sample will be compared with those obtained using conventional microbiology methods for the same sample. Moreover, interobserver agreement will be assessed by the calculation of Cohens Kappa. The clinical value of the NGS-based approach will be estimated by a panel of three independent clinical specialists not associated with the study site, retrospectively identifying potential changes in patients´ management based on NGS results.

Secondary Outcome Measures

Name	Time	Method
1.) Diagnostic or prognostic value of host nucleosome positioning patterns derived from plasma cell free DNA in infants and toddlers with suspected or proven severe sepsis or septic shock, 2.) Diagnostic value of host expression profiles including RNA-derived biomarkers in infants and toddlers with suspected or proven severe sepsis or septic shock, 3.) Diagnostic or prognostic value of methylglyoxal (MG)-derived carbonylstress in infants and toddlers with suspected or proven severe sepsis or septic shock, 4.) Evaluation of antimicrobial resistance patterns and virulence factors, 5.) Evaluation of process times for NGS-based measurements