An assessment of the potential clinical utility of a new multiplex-PCR assay (VYOO®) in the management of ICU patients with sepsis
Organizational Data
- DRKS-ID:
- DRKS00000612
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2011-01-07
- Last update in DRKS:
- 2014-04-14
- Registration type:
- Prospective
Acronym/abbreviation of the study
KS-2009-028 VYOO-MultiSep
URL of the study
No Entry
Brief summary in lay language
VYOO® (SIRS-Lab GmbH) is a molecular diagnostic tool that provides identification and speciation of bacterial and fungal pathogens as well as identification of key decision-influencing bacterial resistances directly from whole blood. The early availability of accurate information on causative pathogens and resistances will allow clinicians to ensure correct and targeted anti-infective therapy at the earliest possible time, which should lead to a more favorable outcome for the patient and reduced mortality rates. Within the study, 2x 5 ml whole blood from 1,000 patients on intensive care units suspected for sepsis (> 18 years) will be withdrawn and tested for presence of pathogens applying the new assay. Prospective data analysis will determine how far the process might be conductive for the outcome of the patients by improved directed therapy in comparison to the established workflow.
Brief summary in scientific language
The study is designed to assess the clinical utility of the multiplex PCR-based new diagnostic tool VYOO® for the detection of sepsis pathogens in whole blood in suspected septic patients on ICU (clinical suspicion of sepsis on ICU according to ACCP/SCCM consensus conference criteria and indication for a blood culture according to Expertengremium Mikrobiologisch-infektiologische Qualitätsstandards, MiQ 3a 2007). The clinical utility of VYOO® is to be assessed by showing sensitivity of at least 20% and specificity of at least 90% for the correct diagnosis of sepsis, as compared with the “true disease state” (“virtual gold standard”) based on the clinical diagnosis of sepsis including cultural tests. Further objectives are whether VYOO® showed pathogens, including fungi, that were not adequately covered by the initial antibiotic regimen; the suitability of the initially chosen antibiotic therapy including patients who had inadequate coverage of fungi in their initial therapy; whether the blood culture result led and retrospectively the VYOO® result could have led to any change of antibiotic therapy; the outcome (as measured by ICU and discharge diagnosis and 28-day mortality) of patients with correct versus incorrect initial antibiotic therapy. In minimum 1000 patiens are to be included for statistical calculation (N=1000, 800 for the assessment of sensitivity, 200 for the assessment of specificity).
Health condition or problem studied
- ICD10:
- A41.9 - Sepsis, unspecified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
No Entry
Endpoints
- Primary outcome:
- 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. 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:
- Investigation whether VYOO® showed pathogens, including fungi, that were not adequately covered by the initial antibiotic regimen. Inquiry of the suitability of the initially chosen antibiotic therapy including patients who had inadequate coverage of fungi in their initial therapy. Inquiry whether the blood culture result led and retrospectively the VYOO® result could have led to any change of antibiotic therapy. Test of the outcome (as measured by ICU and discharge diagnosis and 28-day mortality) of patients with correct versus incorrect initial antibiotic therapy.
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Universitätsmedizin Greifswald Greifswald
- University medical center UK Frankfurt Frankfurt a.M.
- University medical center RWTH Aachen Aachen
- University medical center UK Regensburg Regensburg
- University medical center HDZ Bad Oeynhausen Bad Oeynhausen
- University medical center UK Essen Essen
- University medical center UKE Hamburg Hamburg
- University medical center UK SH Campus Kiel Kiel
- University medical center UK Leipzig Leipzig
- University medical center UK des Saarlandes Homburg/Saar Homburg
- University medical center Medizinische Hochschule Hannover Hannover
- University medical center UK Düsseldorf Düsseldorf
- University medical center UK Köln Köln
Recruitment period and number of participants
- Planned study start date:
- 2011-02-01
- Actual study start date:
- 2011-02-21
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 1000
- Final Sample Size:
- 1050
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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
Addresses
Primary Sponsor
- Address:
- SIRS-Lab GmbHOtto-Schott-Strasse 1507745 JenaGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.sirslab.com
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Medizinische Hochschule Hannover Klinik für PneumologieProf. Dr. med. Tobias WelteCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- +49 511 532 3530
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.mh-hannover.de
Contact for Public Queries
- Address:
- Hannover Clinical Trial Center GmbHDr. Armin PapkallaCarl-Neuberg-Str. 1/K2730625 HannoverGermany
- Telephone:
- +49 511-533 333-0
- Fax:
- +49 511 533 333-99
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.clinical-trial-center.de
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- SIRS-Lab GmbHOtto-Schott-Strasse 1507745 JenaGermany
- Telephone:
- +49 3641 3103100
- Fax:
- +49 3641 3103102
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.sirs-lab.com
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Hochschule HannoverCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- +49-511-5323443
- Fax:
- +49-511-5325423
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2010-01-14
- Ethics committee number:
- OE 9515
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2010-11-25
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Intensivmed 2010 · 47:463–463 DOI 10.1007/s00390-010-0209-y Online publiziert: 4. September 2010 © Springer-Verlag 2010
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry