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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21547
Enrollment
80
Registered
2013-07-29
Start date
2013-07-29
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Sepsis Bacteraemia/ bacteremia Molecular diagnosis bacteria in blood

Interventions

None listed

Sponsors

VU University Medical Center
Lead Sponsor

Eligibility

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
Primary objectives: 1.To determine the diagnostic performance of five molecular assays for the detection of bacteraemia in patients. 2.To evaluate the relationship between the bacterial DNA load (BDL), quantitative culture and culture time-to-positivity in patients with bacteraemia.

Secondary

MeasureTime frame
Secondary objective: 1. 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.

Contacts

Public ContactM. Brand, van den

VU University Medical Center Department of Medical Microbiology and Infection Control Van der Boechorststraat 7

marre.vandenbrand@vumc.nl+31 (0)20 4448679

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)