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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00000612 |
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Date of registration:
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07/01/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An assessment of the potential clinical utility of a new multiplex-PCR assay (VYOO®) in the management of ICU patients with sepsis
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Scientific title:
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An assessment of the potential clinical utility of a new multiplex-PCR assay (VYOO®) in the management of ICU patients with sepsis - KS-2009-028 VYOO-MultiSep
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Date of first enrolment:
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21/02/2011 |
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Target sample size:
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1000 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00000612 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: diagnostic
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Armin
Papkalla |
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Address:
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Carl-Neuberg-Str. 1/K27
30625
Hannover
Germany |
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Telephone:
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+49 511-533 333-0 |
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Email:
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info@clinical-trial-center.de |
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Affiliation:
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Hannover Clinical Trial Center GmbH |
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Name:
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Tobias
Welte |
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Address:
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Carl-Neuberg-Str. 1
30625
Hannover
Germany |
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Telephone:
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+49 511 532 3530 |
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Email:
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welte.tobias@mh-hannover.de |
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Affiliation:
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Medizinische Hochschule Hannover
Klinik für Pneumologie |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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A41.9
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Sepsis, unspecified
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A41.9
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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SIRS-Lab GmbH
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Ethics review
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Status: Approved
Approval date: 25/11/2010
Contact:
ethikkommission@mh-hannover.de
Ethikkommission der Medizinischen Hochschule Hannover
+49-511-5323443
ethikkommission@mh-hannover.de
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