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Verbeterde diagnostiek bij Staphylococcus aureus bacteriëmie

Improved Diagnostic Strategies in Staphylococcus aureus bacteraemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27100
Enrollment
450
Registered
2017-03-31
Start date
2017-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ENG: Staphylococcus aureus bacteraemia, sepsis, endocarditis, infection. NL: Staphylococcus aureus, staphylokokken, endocarditis, infectie, sepsis, bloedvergiftiging.

Interventions

Main cohort study: Observational only cCT sub-study: Cardiac CT (cCT) on 0-72h after inclusion. cCT is semi-blindend: only clinically relevant coindicental findings are reported. Endocarditis is sc

Sponsors

Academic Medical Center, Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: > Adult (aged ≥18yr old) patients with SAB, admitted to the hospital > Written informed consent by patient or legal representative

Exclusion criteria

Exclusion criteria: Main cohort study: > no exclusion criteria cCT sub-study: > inability to provide informed consent by patient > eGFR Life expectancy 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactThomas W. van der Vaart
t.w.vandervaart@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)