Primary objectives1. Determine prospectively the accuracy of proposed clinical criteria to assess the risk of SA-IE and complicated SAB2. Determine the diagnostic accuracy of cCT for SA-IE in patients with SAB3. Determine the diagnostic and…
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
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.
cCT sub-study:
1. Diagnostic accuracy of cardiac CT for the diagnosis of endocarditis in
patients with SAB.
qPCR sub-study:
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 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.
Background 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.
Study objective
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
Study design
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.
Study burden and risks
The main study involves no invasive measurement but patients are asked to fill
in the EQ 5D 5L at inclusion and through telephone interview at 90 days after
discharge.
Participants in the cCT study are subjected to 2-10 mSv of ionizing radiation
and have a small risk of contrast induced nephropathy.
Participants in the qPCR and biobank-substudies are subjected to either one or
three additional venepunctures during the first week after inclusion. Risks
from venepuncture are limited to pain or discomfort during puncture and
formation a hematoma.
Incapacitated persons are excluded from the cCT sub-study. The risks and burden
for incapacitated patients for the main study and the qPCR and biobank
sub-substudies are minimal and these patients can be included after informed
consent by a legal representative. Excluding (temporarily) incapacitated
patients from the main study or qPCR/biobank substudies would greatly limit
generalizability and external validity of study results
Meibergdreef 6
Amsterdam Zuidoost 1105AZ
NL
Meibergdreef 6
Amsterdam Zuidoost 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Positive bloodculture with Staphylococcus aureus
Exclusion criteria
For the main study and the qPCR and Biobank sub-studies: none., For the cCT
substudy: eGFR <45ml/min, pregnancy, female <30 years, inability to provide
informed consent, life-expectancy <4 weeks, hemodynamic instability or
respiratory failure.
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 |
|---|---|
| Other | 26987 (Nederlands Trial Register) |
| CCMO | NL60653.018.17 |