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

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 - Lab-ALERTS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00004159

Enrollment

4516

Registered

2012-07-17

Start date

2012-07-25

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A41.9

Interventions

Group 1: Asservation of blood plasma from remaining routine material after routine diagnositcs during hospital stay. Determination of new biomarker candidates and conventional biomarkers at different

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: I) none; II) infection present upon hospital atmittance; anamnesis of a previous stroke; cardiac arrhythmia; III) none; IV) none

Design outcomes

Primary

Measure	Time frame
Improved receiver operating curve (ROC) values of novel molecular biomarkers and their combinations compared to conventional biomarkers (PCT, CRP, IL-6) for the prediction of: I) Infectious fever origin in patients with neutropenic fever II) Infections in patients after apoplectic stroke III) Progression of a nosocomial infection to severe sepsis / septic shock IV) Progression of a community acquired pneumonia to severe pneumonia / septic pneumonia	—

Measure

Time frame

Improved receiver operating curve (ROC) values of novel molecular biomarkers and their combinations compared to conventional biomarkers (PCT, CRP, IL-6) for the prediction of: I) Infectious fever origin in patients with neutropenic fever II) Infections in patients after apoplectic stroke III) Progression of a nosocomial infection to severe sepsis / septic shock IV) Progression of a community acquired pneumonia to severe pneumonia / septic pneumonia

—

Secondary

Measure	Time frame
Identification of peptides/ proteins underlying discriminatory peaks from the Lab-ALERTS-Pilot study; Development of robust assays suitable for routine procedures; Build up a biobank by collecting plasma samples from patients with neutropenic fever or nosocomial infections	—

Countries

Germany

Contacts

Public ContactMichael Kiehntopf

Institut für Klinische Chemie und Laboratoriumsdiagnostik / Integriertes Forschungs- und Behandlungszentrum Sepsis und Sepsisfolgen

michael.kiehntopf@med.uni-jena.de+4936419325000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026