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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON39300
Enrollment
80
Registered
2012-10-08
Start date
2013-07-31
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

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

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The diagnostic performance of each molecular assay is determined by the sensitivity, specificity, positive predictive value, negative predictive value as compared to culture as a golden standard. Inter-assay variation is determined by measure of agreement and calculation of kappa value.

Secondary

MeasureTime frame
To assess the putative applicability of the molecular assays in routine molecular diagnostics with regard to costs, hands on time and difficulty of the protocol in routine use.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)