To evaluate molecular assays for the detection and quantification of bacterial DNA in blood of patients with bacteraemia. Objectives are to determine the diagnostic performance of five molecular assays for the detection of bacteraemia in patients…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Bloodstream infections are a major cause of mortality and morbidity. Current
routine diagnosis by blood culture is hampered by a fairly long time to
positivity and reduced sensitivity due to already initiated antibiotic therapy.
Molecular diagnosis of bloodstream infection may offer a faster alternative to
blood culture irrespective to antibiotic treatment. In addition, bacterial DNA
load might be an important marker of severity of infection. This study
investigates the performance of several new assays for the detection in
patients with bacteraemia.
Study objective
To evaluate molecular assays for the detection and quantification of bacterial
DNA in blood of patients with bacteraemia. Objectives are to determine the
diagnostic performance of five molecular assays for the detection of
bacteraemia in patients and to evaluate the relationship between bacterial DNA
load (BDL), quantitative culture and culture time-to-positivity in patients
with bacteraemia.
Study design
This study is an observational study in patients with bacteraemia. It is
designed to evaluate five molecular assays, qualitative blood culture and
quantitative blood culture for the detection and quantification of bacteraemia
in patients. For purpose of the study blood is drawn once from patients with
bacteraemia. The study will be performed at the VU university medical center,
department of medical microbiology and infection control, Amsterdam, The
Netherlands.
Study burden and risks
For the purpose of this study one venipuncture (in incapacitated patients blood
is obtained through a central catheter) is performed and approximately 50ml
blood is obtained. The risk and burden of such venipuncture is considered to be
very limited since the amount of blood is small considering the total blood
volume. In addition, severely anaemic patients are not included in this study.
No other participation is required from the patient with the exception of a
very limited physical examination. Patient information is retrieved from the
medical record. Patients will not have any benefit from participation in the
study, but this study will generate important information regarding the
diagnostics of bloodstream infections in the future.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40998.029.12 |