Comparison of multiplex PCR assay for detection of bacterial and fungal DNA and blood cultures in children with suspected sepsis under antibiotic treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00004694

Enrollment

Registered

2013-02-07

Start date

2010-12-20

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

suspected infection under antibiotic treatment R65.0 R65.1

Interventions

Group 1: infants, children and adolescents up to the age of 17: additional blood test (SeptiFast) with the obtained blood cultures

Eligibility

Sex/Gender

All

Age

29 Days to 17 Years

Inclusion criteria

Inclusion criteria: >37 weeks of gestation and older than 28 days; occurence of fever (>38.5°C) or SIRS with suspected infection after either >40 hours of antibiotic treatment or > 2 doses of antibiotics in critically ill patient (admission to ICU).

Exclusion criteria

Exclusion criteria: missing informed consent; additional 1.5 ml blood drawing for SeptiFast might deteriorate patient

Design outcomes

Secondary

Measure	Time frame
comparison of time from blood drwing to result; number of therapy changes due to SeptiFast results; procalcitonin values in patients with positive blood cultures and in patients with positive SeptiFast	—

Primary

Measure	Time frame
rate of positive SeptiFast results in comparison to positive blood culture results	—

Countries

Germany

Contacts

Public ContactChristian Dohna-Schwake

Universitäts-Klinikum, Zentrum für Kinder- und Jugendmedizin

christian.dohna-schwake@uk-essen.de00492017232251

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 1, 2026