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Bacterial Load during ENdocarditis Therapy.


- candidate number9701
- NTR NumberNTR2930
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jun-2011
- Secondary IDsNL35425.029.11 CCMO
- Public TitleBacterial Load during ENdocarditis Therapy.
- Scientific TitleMolecular detection of the bacterial load as a diagnostic and monitoring tool for optimal antibiotic treatment in endocarditis.
- ACRONYMBLENT
- hypothesisThe molecular detection of the bacterial load is useful for diagnostics and therapeutic monitoring in patients with (suspected) bacterial endocarditis.
- Healt Condition(s) or Problem(s) studiedEndocarditis, Monitoring, Diagnosis, Molecular diagnostics, Bacterial load, Real time PCR
- Inclusion criteria1. Adult patients (≥18 years) with suspected endocarditis, admitted in one of the participating hospitals;
2. Written informed consent is obtained.
- Exclusion criteria1. Failure to obtain written informed consent to participate;
2. Endocarditis caused by Coxiella burnetii (Q-fever);
3. An Hb below 5.0 mmol/L;
4. Death before first sample is obtained.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2011
- planned closingdate1-mei-2014
- Target number of participants180
- InterventionsNo interventions; observational study.
- Primary outcome1. Determination of the diagnostic value of mBL for the diagnosis of bacterial endocarditis with endocarditis defined according to Duke criteria;
2. Prognostic value of mBL in patients with endocarditis according to Duke criteria with regard to the occurrence of a complicated course;
3. A descriptive model of the kinetics of mBL related to infectious parameters (CRP, WBC, PCT) in patients with an uncomplicated treatment course of bacterial endocarditis.
- Secondary outcome1. Determination of the diagnostic value of mBL for the diagnosis of bacterial endocarditis compared to blood culture results and laboratory markers (e.g. CRP, procalcitonin, WBC);
2. Prognostic value of mBL in patients with endocarditis according to Duke criteria with regard to other outcome parameters (mortality, surgery);
3. Correlation of mBL at start of therapy with clinical severity scores (PITT bacteremia score, APACHE II score);
4. Correlation of mBL at start of therapy with the occurrence of a complicated treatment course at a later time point.
- TimepointsN/A
- Trial web sitewww.endocarditis.nl
- 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)
- RECORD8-jun-2011 - 16-jun-2011


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