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Technical Evaluation of Brahms PCT Direct

NCT ID: NCT01771029

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-09-30

Brief Summary

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Validation of the technical performance of the BRAHMS PTC direct point-of-care assay under routine conditions with native patient samples. The clinical validation is planned as a method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT). The study hypothesis is to show a highest correlation between the new product and the reference methods.

Detailed Description

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Procalcitonin (PCT) is a highly sensitive and specific marker which can be detected in the blood stream in response to a bacterial infection. In contrast to conventional infection disease markers PCT permits the differential diagnosis between bacterial and viral infections. The marker is implemented on Intensive Care Units (ICU) and Emergency Departments (ED) worldwide since 1996. Until now various technologies all basing on the use of serum or plasma samples are available in the market.

BRAHMS GmbH (Clinical Diagnostics Division of Thermo Fisher Scientific) as manufacturer of the Procalcitonin assays has developed a new quantitative immunochromatographic whole blood point-of-care assay, the BRAHMS PCT direct. The test follows the principle of a sandwich assay with two anti-PCT antibodies, one immobilized on a nitrocellulose membrane and the tracer antibodies labeled with gold.

Validation of the technical performance of the product under routine conditions with native patient samples. The clinical validation is planned as a method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT). The internal pre-studies were performed with blood samples spiked with recombinant PCT and with native patient samples.

The primary objective of this study is to show a highest correlation between BRAHMS PCT direct with the PCT reference method for PCT- positive and negative samples.

The secondary object of this study is to show the advantage of BRAHMS PCT direct in time to result in comparison to the reference method.

Conditions

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Infection

Keywords

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Procalcitonin Infection Point-of-Care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* possible infection at initial presentation
* informed consent

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thermo Fisher Scientific, Inc

INDUSTRY

Sponsor Role collaborator

Philipp Schuetz

OTHER

Sponsor Role lead

Responsible Party

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Philipp Schuetz

PD Dr. med. Oberarzt

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Philipp Schuetz, PD, Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Aarau

Locations

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Pitié Salpetrière. Groupement hospitalière universitaire Est

Paris, Paris, France

Site Status

Klinikum Ernst von Bergmann, gemeinnützige GmbH Akademisches Lehrkrankenhaus der Humboldt-Universität Berlin (Charité)

Potsdam, , Germany

Site Status

Kantonsspital Aarau Innere Medizin

Aarau, Canton of Aargau, Switzerland

Site Status

Countries

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France Germany Switzerland

Other Identifiers

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POC_1

Identifier Type: -

Identifier Source: org_study_id