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

• Conditions: suspected infection under antibiotic treatment; R65.0; R65.1; Systemic Inflammatory Response Syndrome of infectious origin without organ failure; Systemic Inflammatory Response Syndrome of infectious origin with organ failure

• Registration Number: DRKS00004694
• Lead Sponsor: niversitätsklinikum Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-07
• Study Completion: 2014-05-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 39

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of positive SeptiFast results in comparison to positive blood culture results

Secondary Outcome Measures

Name	Time	Method
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