Comparison of novel assays for the molecular detection and quantification of bacteria in patients with bloodstream infections

Completed

Conditions: bacteraemia
bloodstream infection
sepsis (in case blood stream infection sepsis is regularly diagnosed)
10004018

Registration Number: NL-OMON39300

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

- Age >= 18 years
- Bacteraemia with at least one blood culture with growth of Gram-negative bacteria or Gram-positive cocci in chain observed with microscopy.
- Bacteraemia with at least one blood culture with growth of Gram-positive cocci (in clusters) and at least one of the following syndromes suggestive of S. aureus infection: arthritis, wound infection, thrombophlebitis, meningitis, soft tissue infection, vertebral osteomyelitis, splenic abscess or other microbiological evidence for S. aureus infection

Exclusion Criteria

- Blood culture obtained >48 hours
- Intravenous antibiotic therapy >48 hours
- Haematological disorder
- Anaemia (an Hb below 5.5 mmol/L)
- Participation in BLENT-study of patients with endocarditis
- Previous participation in this study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The diagnostic performance of each molecular assay is determined by the<br /><br>sensitivity, specificity, positive predictive value, negative predictive value<br /><br>as compared to culture as a golden standard. Inter-assay variation is<br /><br>determined by measure of agreement and calculation of kappa value. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the putative applicability of the molecular assays in routine<br /><br>molecular diagnostics with regard to costs, hands on time and difficulty of the<br /><br>protocol in routine use.</p><br>