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


- candidate number15206
- NTR NumberNTR4094
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jul-2013
- Secondary IDs12277 
- Public TitleComparison of novel assays for the molecular detection and quantification of bacteria in patients with bloodstream infections: COMBI study
- Scientific TitleComparison of novel assays for the molecular detection and quantification of bacteria in patients with bloodstream infections
- ACRONYMCOMBI
- hypothesisThe aim is to evaluate molecular assays for the detection and quantification of bacterial DNA in blood from patients with bacteraemia.
- Healt Condition(s) or Problem(s) studiedSepsis, Bacteremia, Molecular diagnostics
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 29-jul-2013
- planned closingdate1-mrt-2014
- Target number of participants80
- InterventionsN/A
- Primary outcomePrimary 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 outcomeSecondary 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.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M. Brand, van den
- CONTACT for SCIENTIFIC QUERIESDrs. M. Brand, van den
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD29-jul-2013 - 8-aug-2013


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