Improved Diagnostic Strategies in Staphylococcus aureus bacteraemia

Improved Diagnostic Strategies in Staphylococcus aureus bacteraemia - IDISA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49374

Enrollment

526

Registered

2019-12-05

Start date

2017-07-25

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

Endocarditis sepsis

Interventions

Bacteraemia

Diagnosis

Endocarditis

Staphylococcus aureus

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Positive bloodculture with Staphylococcus aureus

Exclusion criteria

Exclusion criteria: For the main study and the qPCR and Biobank sub-studies: none., For the cCT substudy: eGFR

Design outcomes

Primary

Measure	Time 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	—

Measure

Time 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

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Secondary

Measure	Time 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 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.	—

Measure

Time 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 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.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)