An assessment of the potential clinical utility of a new multiplex-PCR assay (VYOO®) in the management of ICU patients with sepsis
- Conditions
- A41.9Sepsis, unspecified
- Registration Number
- DRKS00000612
- Lead Sponsor
- SIRS-Lab GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1050
Inclusion Criteria
Signed Informed Consent Form by the patient or their legal representative
- All adult (age = 18) patients with suspicion of sepsis, severe sepsis or septic shock (ACCP/SCCM criteria) and indication for blood culture (defined according to Expertengremium Mikrobiologisch-infektiologische Qualitätsstandard” (MiQ 3 a 2007)
Exclusion Criteria
- The additional blood sampling of 10ml (2 x 5 ml) for VYOO® testing is not advisable for medical reasons
- Less than two sets of blood cultures could be taken
- Absolute neutrophil count is less than 1’500 / µl blood
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of the clinical utility of VYOO® in suspected septic patients on ICU, compared with the true disease state” (virtual gold standard”) based on the clinical diagnosis of sepsis including blood and other (cultural) findings / laboratory tests.<br>The results will be collected via eCRF and evaluated prospectively. Data acquisition will be closed when valid data from 1,000 patients are provided for statistical analysis. This number is sufficent for determination of sensitivity and specificity of the assay. A clinical value is given if a sensitivity of in minimum 20% and a specificity if in minimum 90% have been achieved.
- Secondary Outcome Measures
Name Time Method Investigation whether VYOO® showed pathogens, including fungi, that were not adequately covered by the initial antibiotic regimen.<br>Inquiry of the suitability of the initially chosen antibiotic therapy including patients who had inadequate coverage of fungi in their initial therapy.<br>Inquiry whether the blood culture result led and retrospectively the VYOO® result could have led to any change of antibiotic therapy.<br>Test of the outcome (as measured by ICU and discharge diagnosis and 28-day mortality) of patients with correct versus incorrect initial antibiotic therapy.