Investigation and validation of the diagnostic performance of new biomarker candidates for (I) the early detection of an infectious origin of neutropenic fever and for the prediction of (II) an infection of patients after apoplectic stroke and the progression of (III) a nosocomial infection or (IV) a community acquired pneunomia to a severe sepsis/ septic shock
- Conditions
- A41.9Sepsis, unspecified
- Registration Number
- DRKS00004159
- Lead Sponsor
- Institut für Klinische Chemie und Laboratoriumsdiagnostik / Integriertes Forschungs- und Behandlungszentrum Sepsis und Sepsisfolgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1018
Inclusion Criteria
I) patients with hemato-malignancies who are expected to develop neutropenia during/ after chemotherapy, age = 18 (297 patients, recruitment in this study);
II) Ischemic stroke in the territory of A. cerebri media (or beyond), age = 18, NIH stroke score (NIHSS) > 8 (136 patients, recruitment in PRED-SEP study, DRKS00003392);
III) hospital stay of >48 hours and nosocomial infection (4219 patients, recruitment in this study);
IV) patienten with community acquired pneumonia (400 patients, recruitment in PROGRESS-CAP study)
Exclusion Criteria
I) none;
II) infection present upon hospital atmittance; anamnesis of a previous stroke; cardiac arrhythmia;
III) none;
IV) none
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improved receiver operating curve (ROC) values of novel molecular biomarkers<br>and their combinations compared to conventional biomarkers (PCT, CRP, IL-6)<br>for the prediction of:<br>I) Infectious fever origin in patients with neutropenic fever<br>II) Infections in patients after apoplectic stroke<br>III) Progression of a nosocomial infection to severe sepsis / septic shock<br>IV) Progression of a community acquired pneumonia to severe pneumonia / septic pneumonia
- Secondary Outcome Measures
Name Time Method Identification of peptides/ proteins underlying discriminatory peaks from the Lab-ALERTS-Pilot study;<br>Development of robust assays suitable for routine procedures;<br>Build up a biobank by collecting plasma samples from patients with neutropenic fever or nosocomial infections