|- candidate number||26987|
|- NTR Number||NTR6669|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-mrt-2017|
|- Secondary IDs||2017_094 METC AMC|
|- Public Title||Verbeterde diagnostiek bij Staphylococcus aureus bacteriŽmie|
|- Scientific Title||Improved Diagnostic Strategies in Staphylococcus aureus bacteraemia|
|- hypothesis||Primary objectives |
1. Determine prospectively the accuracy of proposed clinical criteria to assess the risk of SA-IE and complicated SAB
2. Determine the diagnostic accuracy of cCT for SA-IE in patients with SAB
3. Determine the diagnostic and prognostic value of serial bacterial load measurement(s) (quantitative PCR) for metastatic S. aureus infection
4. Find biomarkers for SA-IE and complicated SAB using a biobank
5. Identify bacterial virulence factors for SA-IE and complicated SAB
|- Healt Condition(s) or Problem(s) studied||Sepsis, Staphylococcus aureus, Endocarditis, Bacteremia|
|- Inclusion criteria||> Adult (aged ≥18yr old) patients with SAB, admitted to the hospital |
> Written informed consent by patient or legal representative
|- Exclusion criteria||Main cohort study:|
> no exclusion criteria
> inability to provide informed consent by patient
> eGFR <45ml/min at time of inclusion
> Life expectancy <4 weeks
> Known or suspected allergy to iodine contrast medium
> Haemodynamic instability or respiratory failure expected to last >48hsr
> female sex and aged below 30 years
> known pregancy
qPCR and biobank substudies:
> informed consent >36h after notification of positive culture
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jul-2017|
|- planned closingdate||1-jun-2019|
|- Target number of participants||450|
|- Interventions||Main cohort study:|
Cardiac CT (cCT) on 0-72h after inclusion. cCT is semi-blindend: only clinically relevant coindicental findings are reported. Endocarditis is scored later by radiologist & cardiologist blinded to outcome and echocardiography results
blood for in house S. aureus qPCR is drawn on inclusion and/or day 3 and 7 after inclusion
blood for Biobank is drawn on inclusion and/or day 3 and 7 after inclusion
|- Primary outcome||Main cohort study: |
1. Presence or absence of infective endocarditis and/or complicated SAB, as classified by study adjudication committee at the end of the study based on all clinical information up to 90 days after discharge.
1. Diagnostic accuracy of cardiac CT for the diagnosis of endocarditis in patients with SAB.
1. Diagnostic accuracy of qPCR for the diagnosis of complicated SAB and SA-IE bacteraemia in patients with SAB. Biobank sub-study:
1. The diagnostic and prognostic value of host response biomarkers during antimicrobial therapy for the diagnosis of complicated SAB and SA-IE
|- Secondary outcome||Main cohort study: |
1. Diagnostic accuracy (sensitivity, specificity, positive and negative predictive values) of clinical criteria for the diagnosis of endocarditis and/or complicated SAB
2. Exploratory analysis of differences in bacterial virulence factor expression between patients with uncomplicated SAB and patients with SA-IE and/or patients with complicated SAB.
3. Infection related mortality and morbidity, as classified by study adjudication committee at the end of the study based on all clinical information up to 90 days after discharge
4. Health care related costs up to 90 days after discharge.
5. Quality of life (as measured using EQ 5D 5L) on inclusion and 45 and 90 days after discharge. cCT sub-study:
1. Cost-effectiveness of a cardiac-CT-for-all algorithm in patients with SAB, compared to normal diagnostic work flow.
2. Cost-effectiveness of a cardiac-CT algorithm only for patients classified as high-risk according to clinical criteria. 3. Patient comfort during cCT compared to TEE.
|- Timepoints||90 days after discharge is the final follow-up for survival and diagnosis endocarditis |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MD Thomas W. van der Vaart|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J.M. Prins|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Innovatiefonds zorgverzekeraars, Academic Medical Center (AMC), University Medical Center Utrecht (UMCU)|
|- Brief summary||Staphylococcus aureus bacteraemia (SAB) is a frequent cause of community and hospital-acquired infection. The clinical spectrum ranges from uncomplicated infection of an intravascular catheter to fulminant endocarditis with metastatic infection. Recognition of endocarditis (SA-IE) and other forms of complicated SAB is an important clinical issue, but there have been few advances in diagnostic tests. The IDISA study aims to improve diagnosis of complications in patients with SAB by testing new, promising diagnostic modalities.|
The IDISA study is a multicentre prospective cohort study with one main cohort and three sub-studies. Patients can participate in as many sub-studies as they consent to. These sub-studies are: cCT sub-study qPCR sub-study Biobank sub-study The biobank and qPCR sub-studies have two variants. One variant includes one venapuncture after inclusion only The other variant includes one venapuncture after inclusion and two subsequent venapunctures on day 3 and 7 after inclususion.
Results from the diagnostic tests in the sub-studies are not shared with treating physicians. The study will not interfere with patient care. Patients will receive usual care during hospital admission and follow-up.
|- Main changes (audit trail)|
|- RECORD||31-mrt-2017 - 11-sep-2017|